We are an Engineering Consulting Firm that provides specialized technical services to the Pharmaceutical, Biotechnology, and Medical Device industries throughout Puerto Rico. Our team of expert engineers delivers innovative, compliant, and efficient solutions that support our clients’ operations and regulatory goals.
We are seeking three (3) Project Engineers with experience in construction, facility improvements, and regulated manufacturing environments. These openings are for:
Project Engineer – Mechanical Engineering
Project Engineer – Electrical Engineering
Project Engineer – Civil Engineering
Each engineer will support a major facility/structural improvement project by providing technical, planning, and coordination support across all phases of project execution.
Position: Project Engineer (Mechanical / Electrical / Civil)Reports To: Project Manager & Director of Operations
Location: Puerto Rico
Employment Type: Full-time (Project-Based Role)
The Project Engineer is responsible for the monitoring and control of project initiation, planning, execution, construction oversight, installation, commissioning, qualification, and closing.
This role ensures that every assigned project maintains:
a complete and clear scope of work
timeline and construction schedule
budget control and cost estimates
construction quality program
procurement and bidding support
risk identification and mitigation
compliance with local/federal regulations and building codes
Each Project Engineer will provide discipline-specific support (Mechanical, Electrical, or Civil) and must be capable of working within active construction sites and regulated manufacturing facilities.
Duties and ResponsibilitiesProject InitiationCollect project requirements prior to planning.
Define objectives, business needs, and project constraints.
Prepare statements of work aligned to Mechanical/Electrical/Civil scopes.
Identify discipline-specific codes, standards, and regulatory requirements.
Document preliminary risks and project assumptions.
PlanningPrepare project management plan sections related to mechanical, electrical, or civil scopes.
Support scheduling from engineering design through construction, commissioning, and turnover.
Identify activity sequences, durations, and discipline-specific resources.
Assist in cost estimating and budget monitoring.
Develop quality metrics related to construction and engineering deliverables.
Prepare procurement packages, specifications, and drawings.
Participate in internal/external resource planning.
ExecutingSupport construction oversight for discipline-specific activities (mechanical systems, electrical infrastructure, civil/structural improvements).
Participate in construction walkdowns, inspections, testing, and commissioning activities.
Review submittals, RFIs, drawings, shop drawings, and vendor documentation.
Conduct meetings with contractors, vendors, and engineering teams.
Support project file management and document distribution.
Ensure compliance with construction codes, SOPs, and regulatory standards.
Assist in progress tracking, change control, and issue resolution.
ClosingContribute to turnover package preparation, including as-builts and test reports.
Support closeout of construction contracts, invoices, and change orders.
Confirm completion of discipline-specific requirements.
Document lessons learned.
Support project capitalization.
RequirementsStrong customer service and results orientation.
Ability to manage multiple engineering and construction stakeholders.
Knowledge of regulatory compliance, construction safety, and building codes.
Strong planning, scheduling, and documentation skills.
Excellent interpersonal abilities: communication, teamwork, negotiation, problem-solving.
Ability to work in construction environments (field inspections, walkdowns, observations).
EducationBachelor’s degree in one of the following:
Mechanical Engineering (1 vacancy)
Electrical Engineering (1 vacancy)
Civil Engineering (1 vacancy)
ExperienceMinimum 5 years of relevant experience (regulated industry preferred).
Experience in construction, facility improvements, capital projects, or infrastructure upgrades is strongly preferred.
Required SkillsStrong written and verbal communication skills in English and Spanish.
Ability to generate concise engineering and construction documentation.
Proficiency with MS Office 365.
Ability to interpret engineering drawings and construction plans.
Preferred SkillsMS Project, SAP, TrackWise experience.
Experience in commissioning, qualification, and engineering documentation.
Knowledge of building, mechanical, electrical, and/or structural codes.
Experience coordinating contractors and performing field inspections.
Lean, Six Sigma, or engineering certifications.
Licenses and CertificationsEngineer in Training (EIT): acceptable.
Professional Engineer (PE) License: preferred but not required.
Construction safety certifications: preferred.
Physical, Mental, and Environmental RequirementsAvailability to work after hours or weekends when required by the project.
Ability to work in fast-paced construction environments.
Willingness to support any legal business activity beneficial to the company.
Read LessSmart Precise Solutions, Inc. (SPS, Inc.) is an engineering consulting firm dedicated to delivering high-quality, reliable, and efficient professional services to the Pharmaceutical, Biotechnology and Medical Device regulated industries in Puerto Rico. Our team of experts supports clients in project management, engineering, compliance, quality, environmental health & safety, and operations. We are committed to excellence, innovation, and ensuring alignment with technical, operational, and regulatory requirements.
Position SummaryThe Buyer / Procurement will be responsible for planning, coordinating, and executing all procurement activities required to support the project. This position manages supplier sourcing, quotation activities, purchasing negotiations, PO issuance, order follow-up, and documentation control for all materials, tools, equipment, and services related to the project. The Buyer / Procurement works closely with Project Management, Engineering, Quality, Document Control, and Accounting to ensure procurement activities are accurate, compliant, timely, and aligned with project budgets and specifications.
This role requires strong organizational skills, attention to detail, a thorough understanding of procurement processes within regulated industries, and the ability to work independently while supporting a multidisciplinary team.
Key ResponsibilitiesSupplier Management & SourcingIdentify, evaluate, and maintain a qualified supplier base that meets project requirements and industry standards.
Request and assess quotations from multiple vendors, ensuring clarity in technical specifications, delivery expectations, and compliance requirements.
Conduct market research to identify cost-saving opportunities, alternative suppliers, and improved sourcing strategies.
Purchasing OperationsPrepare, review, and issue Purchase Orders (POs) in accordance with company policies and client/project requirements.
Verify that all purchasing requests include complete specifications, drawings, quantity needs, quality requirements, and approval signatures.
Negotiate pricing, payment terms, delivery schedules, and service agreements to secure the most competitive and compliant procurement outcome.
Track order status from issuance to delivery, ensuring suppliers meet lead times and contractual obligations.
Manage change orders, PO revisions, and updates as needed.
Documentation, Traceability & ComplianceMaintain complete and organized purchasing records, including quotes, POs, contracts, delivery receipts, certifications, and correspondence.
Ensure all procurement documentation follows regulatory expectations typical in pharmaceutical/biotech environments.
Support audit readiness by ensuring traceability, accuracy, and controlled documentation.
Verify that all purchased items comply with required specifications, technical drawings, material certifications, and quality standards.
Cross-Functional CollaborationCoordinate with Engineering and Project Management on procurement schedules, material availability, and budget tracking.
Work closely with warehouse/receiving to confirm deliveries, inspect materials, and resolve discrepancies.
Collaborate with Document Control to ensure proper filing and integration of procurement records into the project Turnover Package (TOP).
Support Accounting/Finance by verifying invoices, reconciling discrepancies, and ensuring proper documentation for payment releases.
Performance MonitoringMaintain supplier performance metrics including delivery accuracy, responsiveness, quality issues, and compliance.
Identify and support corrective actions related to late deliveries, non-conformances, or invoice inconsistencies.
Provide frequent procurement updates, cost summaries, and risk alerts to project leadership.
Required Knowledge, Skills & AbilitiesStrong understanding of procurement processes within regulated industries (pharma/biotech/medical device preferred).
Ability to read and interpret technical specifications, drawings, and equipment descriptions.
Strong negotiation, communication, and supplier-management skills.
Excellent organization and documentation accuracy.
Ability to manage multiple purchasing tasks in a fast-paced project environment.
Proficiency in Microsoft Office 365, Excel, Outlook, SharePoint, and procurement/ERP systems.
Strong analytical skills to compare quotes, evaluate cost impacts, and support budget alignment.
Ability to work with minimal supervision while actively supporting team objectives.
EducationBachelor’s degree required, Business Administration, Supply Chain Management, Operations, Engineering, or a related field preferred.
Experience1–3 years of experience in purchasing, procurement, supply chain, or related roles.
Experience supporting engineering or construction projects preferred.
Experience in pharmaceutical, medical device, biotech, or similarly regulated industries is highly desirable.
Tools, Systems & RequirementsOffice 365 (Word, Excel, Outlook, SharePoint)
Procurement systems or ERP tools (SAP, Oracle, NetSuite, or similar preferred)
Ability to maintain organized digital records for audits and project turnover packages
Familiarity with procurement compliance frameworks in regulated industries
Working ConditionsProject-based environment with interaction across engineering, operations, and quality teams.
May require occasional site visits or coordination with warehouse/receiving personnel.
Must adhere to all client, company, and regulatory safety and documentation policies.
Read LessWe are an Engineering Consulting Firm that provides specialized technical services to the Pharmaceutical, Biotechnology, and Medical Device industries throughout Puerto Rico. Our team of expert engineers delivers innovative, compliant, and efficient solutions that support our clients’ operations and regulatory goals.
We are seeking an experienced Master Scheduler to support a major project for one of our key clients.
Position: Scheduler / Planner – Large-Scale Facility/Structural ProjectReports To: Project Manager / Director of Operations
Location: Main Office
Employment Type: Full-time (Project-Based Role)
The Scheduler / Planner is responsible for developing, maintaining, and controlling the complete project schedule for a large-scale structural improvement and facility upgrade project within a regulated manufacturing environment.
This role ensures all activities, milestones, dependencies, and deliverables are clearly defined, tracked, and aligned with project goals. The Scheduler / Planner will coordinate with engineers, contractors, procurement, operations, and stakeholders to maintain accurate and realistic schedules that support timely project execution.
This position does not require being an engineer, although a background in Industrial Engineering or similar is preferred if accompanied by strong scheduling experience.
Key ResponsibilitiesSchedule Development & MaintenanceDevelop the project’s master schedule covering engineering, procurement, construction, commissioning, and turnover phases.
Build logical activity relationships, dependencies, and sequencing to reflect construction workflows and regulatory requirements.
Establish critical path, key milestones, and deliverables.
Integrate schedules from contractors, subcontractors, and vendors into a unified master plan.
Maintain the schedule throughout the project life cycle with timely updates and forecast adjustments.
Project CoordinationCollaborate with Project Manager, Project Engineers (Mechanical, Electrical, Civil), contractors, and procurement teams to capture accurate schedule data.
Participate in daily/weekly meetings to gather progress updates and identify delays or risks.
Ensure alignment between engineering deliverables, procurement timelines, and construction activities.
Coordinate schedule impacts due to change orders, scope adjustments, or regulatory events.
Monitoring & ControlTrack progress against baseline schedules using earned value, percent complete, and other metrics.
Identify schedule risks, delays, and deviations; provide mitigation recommendations.
Prepare and issue weekly and monthly schedule reports for leadership and stakeholders.
Maintain historical schedule records for forecasting and lessons learned.
Support recovery plans when schedule slippage occurs.
Documentation & CommunicationPrepare Gantt charts, dashboards, and visual schedule summaries for leadership.
Communicate timeline expectations clearly to contractors and internal teams.
Document all changes, delays, and schedule impacts.
Support presentations to client representatives and project leadership.
Required QualificationsBachelor's degree, Industrial Engineering, Project Management, Construction Management, or related field are preferred.
3–5+ years of experience in project scheduling for construction, facility upgrades, capital projects, or industrial projects.
Strong proficiency in Microsoft Project, Microsoft Planner, or equivalent scheduling tools.
Ability to read and interpret engineering drawings, construction plans, and project documentation.
Strong analytical skills for sequencing, critical path analysis, and forecasting.
Strong communication skills in English and Spanish.
Ability to work in fast-paced environments and large, multi-discipline projects.
Preferred QualificationsExperience scheduling projects in pharmaceutical, medical device, or other regulated industries.
Experience integrating multiple contractor schedules into a single master plan.
Experience with earned value management (EVM), S-curves, KPIs, and other schedule-tracking tools.
Experience with project scheduling software
Construction scheduling experience preferred.
Skills & CompetenciesScheduling & Planning
Critical Path Method (CPM)
Construction & Engineering Coordination
Communication & Reporting
Risk Identification
Organization & Time Management
Problem Solving
Multi-tasking
Stakeholder Interaction
Physical, Mental & Environmental RequirementsAbility to attend on-site meetings, walkdowns, and construction progress inspections.
Flexibility to work outside regular hours when project needs require it.
Ability to work within active construction or facility improvement environments.
Read LessWe are an Engineering Consulting Firm that provides specialized technical services to the Pharmaceutical, Biotechnology, and Medical Device industries throughout Puerto Rico. Our team delivers innovative, compliant, and efficient solutions that support our clients’ operations and regulatory goals.
We are seeking a Part-Time Cost Control / Estimator to support a major construction and facility improvement project for one of our key clients.
Position: Cost Control / Estimator (Part-Time)Reports To: Project Manager / Director of Operations
Location: Main Office
Employment Type: Part-Time – Project-Based Role
Education: Bachelor’s Degree in Engineering, Construction Management, Architecture, or related field (required)
The Part-Time Cost Control / Estimator is responsible for preparing accurate and detailed cost estimates for a large-scale structural improvement and facility upgrade project.
This role involves analyzing project drawings, specifications, materials, labor, subcontractor quotes, and timelines to produce reliable cost evaluations. The Cost Control / Estimator will collaborate closely with the Project Manager, Project Engineers, Master Scheduler, and procurement teams to ensure cost estimates align with the project’s scope and budget requirements.
Because this is a part-time role, work hours will be adjusted based on project estimating needs, deliverable deadlines, and phases of construction.
Key ResponsibilitiesCost EstimatingPrepare cost estimates for engineering, procurement, construction, and subcontracted work.
Perform quantity takeoffs from civil, mechanical, electrical, and architectural drawings.
Analyze project scope and identify cost impacts or risks.
Develop pricing sheets, cost models, and estimate templates.
Maintain updated cost databases and historical pricing references.
Bid & Proposal SupportRequest and review subcontractor and vendor quotes.
Perform cost comparisons and recommend the most suitable vendors.
Support the preparation of bid packages and cost summaries.
Provide cost clarifications and breakdowns as needed.
Project CoordinationWork with the Project Manager, Master Scheduler, and engineers to ensure estimates match current project requirements.
Coordinate with procurement to validate material and equipment pricing.
Identify cost risks, escalation factors, and contingency needs.
Ensure estimates align with the project budget.
Monitoring & ReportingPrepare estimate summaries, detailed breakdowns, and executive-level cost reports.
Update estimates based on scope changes or schedule impacts.
Assist in evaluating change orders and pricing additional work.
Support cost tracking and budget updates as needed.
Required QualificationsBachelor’s degree in Engineering, Construction Management, Architecture, Quantity Surveying, or a related field.
3–5+ years of experience in construction estimating, facility upgrades, infrastructure, or capital projects.
Ability to read and interpret drawings, specifications, and construction documents.
Strong knowledge of construction materials, labor requirements, subcontractor pricing, and cost drivers.
Proficiency in MS Excel and estimating tools/software.
Excellent analytical, mathematical, and organizational skills.
Strong communication skills in English and Spanish.
Ability to perform effectively in fast-paced or time-sensitive project phases.
Preferred QualificationsExperience estimating projects in pharmaceutical or medical device industries.
Experience using construction estimating software (ProEst, RSMeans, Bluebeam, OST, etc.).
Familiarity with capital project budgeting and cost control.
Experience working with procurement teams and subcontractor bid evaluations.
Skills & CompetenciesCost estimating & takeoffs
Attention to detail
Analytical thinking
Problem solving
Cost modeling
Vendor/subcontractor coordination
Time management
Construction & engineering understanding
Communication & reporting
Physical, Mental & Environmental RequirementsAbility to work partially on-site if required.
Ability to review plans and perform takeoffs for extended periods.
Ability to work flexible hours based on the needs of the project.
Read LessWe are an Engineering Consulting Firm that provides specialized technical services to the Pharmaceutical, Biotechnology, and Medical Device industries throughout Puerto Rico. Our team delivers innovative, compliant, and efficient solutions that support our clients’ operations and regulatory goals.
We are seeking a Document Control Specialist to support a large-scale facility/structural improvement project for one of our key clients.
Position: Document Control Specialist – Project SupportReports To: Project Manager / Director of Operations
Location: Main Office
Employment Type: Full-time – Project-Based Role
Education: Bachelor’s Degree (required)
The Document Control Specialist is responsible for managing, organizing, and maintaining all project documentation throughout the lifecycle of a large construction and facility improvement project.
This role functions similarly to an Administrative Assistant with strong project documentation experience, ensuring accurate record-keeping, contract file management, controlled document distribution, version tracking, and the preparation of the Project Turnover Package.
The role requires strong organizational skills, attention to detail, and the ability to manage high volumes of documentation in a fast-paced and highly regulated environment.
Key ResponsibilitiesDocument ManagementMaintain and control all project documents including engineering drawings, specifications, submittals, RFIs, meeting minutes, reports, logs, permits, contracts, and correspondence.
Ensure all documents follow the project’s document control processes, naming conventions, revision control, and approval workflows.
Manage document distribution to internal teams, contractors, suppliers, and client representatives.
Track and file incoming and outgoing documentation, ensuring proper authorization.
Maintain accurate logs for RFIs, submittals, transmittals, change orders, and similar project records.
Turnover Package PreparationLead the compilation and organization of the Project Turnover Package including:
as-built drawings
test reports
inspection records
commissioning & qualification documents
warranties
vendor data
certificates and closeout documentation
Ensure all turnover documents meet client and regulatory requirements.
Coordinate with engineering, contractors, and quality teams to collect all required documentation.
Administrative & Project SupportOrganize and maintain project folders (physical and digital).
Support scheduling of meetings, document distribution, and communication between project stakeholders.
Assist with preparation of presentations, reports, and summaries.
Support contract documentation including filing, tracking contract revisions, and monitoring vendor compliance.
Maintain version control and ensure proper archival of all project records.
Compliance & QualityEnsure documentation complies with internal procedures, client requirements, and industry standards.
Support audits and reviews of project documentation.
Maintain confidentiality and strict control over sensitive information.
Required QualificationsBachelor’s Degree (BA) required (Business Administration, Engineering, Project Management, or related field preferred).
3–5 years of experience in document control, administrative project support, or similar roles.
Experience working in construction, engineering, or regulated industry projects.
Strong organizational skills and attention to detail.
Ability to manage high-volume documentation under pressure.
Proficiency in MS Office 365 (Word, Excel, Outlook, PowerPoint).
Ability to learn and manage document control systems.
Excellent communication skills in English and Spanish.
Preferred QualificationsExperience with project contract documentation.
Familiarity with construction project terminology and workflows.
Experience with submittal logs, RFI logs, and project tracking tools.
Experience preparing turnover packages for construction or engineering projects.
Knowledge of SharePoint, OneDrive, or similar document management platforms.
Skills & CompetenciesOrganization & filing
Documentation accuracy
Recordkeeping & logs
Attention to detail
Deadline management
Communication
Confidentiality
Team coordination
Multi-tasking
Data entry & tracking
Physical, Mental & Environmental RequirementsAbility to work in an office or project site environment.
Ability to sit, organize files, and manage documentation for extended periods.
Ability to visit project areas as required.
Ability to work extended hours when project deadlines require it.
Read LessWe are an Engineering Consulting Firm that provides specialized technical services to the Pharmaceutical, Biotechnology, and Medical Device industries throughout Puerto Rico. Our team of expert engineers delivers innovative, compliant, and efficient solutions that support our clients’ operations and regulatory goals.
We are seeking an experienced EHS Specialist to support a major facility/structural improvement project within a regulated environment.
Position: EHS Technician (Safety Technician / Safety Officer)Reports To: EHS Lead / Project Manager / Director of Operations
Location: Main Office
Employment Type: Full-time – Project-Based Role
The EHS Specialist is responsible for supporting all Environmental, Health, and Safety activities throughout a large-scale construction and facility improvement project.
This role includes oversight of waste handling, verification of tools and equipment safety, implementation of OSHA requirements, safety inspections, EHS documentation, and continuous monitoring of safe work practices across the project site.
This position functions similarly to a Safety Officer within the project environment.
Key ResponsibilitiesSafety & Occupational HealthConduct daily and weekly safety inspections across construction areas.
Ensure contractors comply with OSHA standards and site safety procedures.
Inspect tools, equipment, and machinery to verify safe operating conditions.
Monitor proper use of PPE (Personal Protective Equipment).
Support the implementation of Hot Work Permits, Confined Space Permits, Work at Heights protocols, and other controls.
Report unsafe conditions, hazards, and non-compliance to leadership.
Waste ManagementOversee proper handling, labeling, storage, and disposal of project-generated waste.
Coordinate waste pickup, storage, and transfer with approved vendors.
Maintain waste management documentation according to environmental regulations.
Ensure proper handling of hazardous waste, universal waste, chemicals, oils, batteries, and construction debris.
Compliance & DocumentationMaintain EHS records including inspections, incident reports, near misses, permits, and checklists.
Participate in internal and client audits.
Prepare weekly safety reports and summaries.
Ensure compliance with local, state, and federal safety and environmental regulations.
Training & SupportEnsure project personnel complete required safety training before entering the site.
Provide basic safety orientations to new contractors and project personnel.
Support the EHS Lead in safety initiatives and culture-building activities.
Required QualificationsOSHA 30 – Construction (required).
Bachelor’s degree in Science, Environmental Health, Engineering, Occupational Safety, or related field.
1–3 years of experience in EHS roles, preferably in construction, manufacturing, or regulated industry projects.
Knowledge of OSHA regulations, EPA requirements, and waste management practices.
Ability to work in active construction environments (heights, walkdowns, inspections).
Strong written and verbal communication skills in English and Spanish.
Ability to prepare clear and organized documentation.
Preferred QualificationsHAZWOPER 40-hour certification (if applicable).
Hazardous waste handling certification (preferred).
First Aid / CPR certification.
Experience supporting EHS programs in large projects.
Skills & CompetenciesAttention to detail
Hazard identification
Strong observation skills
Organization & documentation
Communication & teamwork
Problem solving
Regulatory compliance
Contractor coordination
Physical, Mental & Environmental RequirementsAbility to walk construction sites, climb stairs, and support field inspections.
Ability to work extended hours as needed by the project.
Ability to work in active construction and industrial environments.
Ability to lift 25–40 lbs occasionally.
Read LessWe are an Engineering Consulting Firm that provides specialized technical services to the Pharmaceutical, Biotechnology, and Medical Device industries throughout Puerto Rico. Our team delivers innovative, compliant, and efficient solutions that support our clients’ operations and regulatory goals.
We are seeking a Part-Time Project Inspector with strong civil/structural engineering expertise to support a major structural and facility improvement project.
Position: Project Inspector – Civil/Structural (Part-Time)Reports To: Project Manager / Director of Operations
Location: Main Office
Employment Type: Part-Time – Project-Based Role
Licensing: Professional Engineer (PE) Required
Preferred: Engineer-in-Training (EIT) or Structural Specialty
The Part-Time Project Inspector is responsible for conducting field inspections, construction oversight, structural verifications, and compliance assessments for a large-scale structural/facility improvement project in a regulated environment.
This position requires a licensed Professional Engineer (PE) in Civil Engineering (Structural emphasis preferred). The Project Inspector ensures construction activities meet approved engineering drawings, structural designs, codes, and safety standards.
Because this is a part-time position, work hours will be defined based on construction phases, inspection needs, contractor schedules, and project milestones.
Key ResponsibilitiesConstruction & Structural InspectionPerform part-time field inspections of civil/structural and facility improvement work.
Verify construction adherence to approved drawings, calculations, codes, and specifications.
Inspect concrete foundations, rebar, steel structures, supports, anchors, and structural assemblies.
Observe installation of utilities, platforms, structural penetrations, and load-bearing components.
Identify non-conformities, deviations, deficiencies, and unsafe conditions.
Compliance & Engineering ReviewEnsure compliance with applicable structural codes (IBC, ACI, AISC, ASCE), OSHA construction rules, and project specifications.
Review submittals, RFIs, shop drawings, and technical documents related to civil/structural scope.
Provide technical guidance to the Project Manager and engineering team based on field observations.
Support verification of contractor compliance with engineering and quality standards.
Documentation & ReportingPrepare inspection reports, daily/weekly logs (as needed), photographs, and non-conformance reports.
Document all structural-related observations, deficiencies, and progress.
Assist with punch lists and turnover documentation for structural components.
Coordination & CommunicationCommunicate inspection findings clearly to contractors, engineers, and project leadership.
Participate in project meetings as required.
Coordinate inspection scheduling with contractors, quality teams, and client representatives.
Support resolution of construction or structural issues identified during inspections.
Required QualificationsProfessional Engineer (PE) License – REQUIRED in Civil/Structural Engineering.
Bachelor’s degree in Civil Engineering or Structural Engineering.
3–7+ years of experience in structural inspection, civil engineering, or construction oversight.
Experience working with structural plans, calculations, and engineering specifications.
Ability to perform inspections in active construction environments.
Strong knowledge of structural codes, construction materials, and safety requirements.
Excellent communication skills in English and Spanish.
Ability to prepare clear and detailed inspection reports.
Preferred QualificationsEngineer-in-Training (EIT) or Structural specialization preferred.
Experience working in pharmaceutical or other regulated industries.
Experience in facility upgrades, structural modifications, or capital projects.
Experience performing structural assessments and field verifications.
Familiarity with construction workflows and project coordination.
Skills & CompetenciesStructural and civil engineering knowledge
Construction field inspection
Code interpretation & compliance
Documentation & reporting
Critical thinking & problem solving
Safety awareness
Communication & stakeholder interaction
Technical analysis
Physical, Mental & Environmental RequirementsAbility to walk construction sites, climb stairs, and access elevated structures.
Ability to work outdoors or in industrial environments.
Flexibility to work part-time hours based on project needs.
Ability to carry inspection tools and equipment as required.
Read LessProvide high-level administrative support to executives by managing schedules, preparing reports, coordinating meetings, and handling communication efficiently. This role requires discretion, attention to detail, and the ability to manage multiple priorities.
Key ResponsibilitiesDraft and prepare correspondence, reports, memos, and other documents using Microsoft Office tools.
Manage calendars, schedule meetings, and coordinate conference calls.
Handle phone calls, emails, and visitors; route communication appropriately.
Organize meetings, prepare agendas, take minutes, and distribute them.
Maintain filing systems and manage internal records and databases.
Conduct research and compile data for presentations and executive reports.
Assist with basic bookkeeping and financial tracking.
Coordinate office services, including supplies, housekeeping, and vendor relations.
Process payroll information and support HR functions when needed.
Support social media management and use of Google Apps and QuickBooks (preferred).
LocationThis position is completely on-site at 40 PR-165, Suite 301, Guaynabo, 00966. This position will work shifts from 8:00 a.m. to 5:00 p.m., Monday through Friday. The candidate preferably resides within 45 to 60 minutes of the work location during peak traffic hours.
RequirementsEducation:
Bachelor’s degree in Office Management, Business Administration, or a related field.
Experience:
Minimum of 2 years in an administrative support role.
Language:
Fluent in both Spanish and English (oral, written, and reading comprehension).
Technical Skills:
Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Strong knowledge of administrative procedures and office management systems.
Experience with QuickBooks, Google Apps, and social media tools (preferred).
Soft Skills:
Excellent written and verbal communication.
High ethical standards, self-motivated, and able to work independently.
Attention to detail, strong organizational skills, and problem-solving ability.
Service-oriented and professional demeanor.
Other Requirements:
Must be legally authorized to work in Puerto Rico.
Ability to use standard office equipment (computer, printer, etc.).
Job Title: Computer System Validation (CSV) Engineer
Location: Metropolitan Area
Job Type: Full-time
Industry: Pharmaceutical / Medical Devices
Experience Required: 3-5 yrs
Languages: Fluent in English and Spanish
We are seeking an experienced Computer System Validation (CSV) Engineer to support the lifecycle of computer system validation activities within a manufacturing environment for pharmaceutical and medical device products. The ideal candidate will be responsible for developing, maintaining, and executing validation protocols and ensuring full compliance with regulatory and internal standards such as FDA regulations, 21 CFR Part 11 and Part 820.
Key ResponsibilitiesLead the validation of computer systems, production equipment, and related procedures to ensure compliance with regulatory and business requirements.
Write and execute validation protocols including IQ, OQ, PQ, and cycle development, and prepare associated final reports.
Conduct periodic reviews of the validated state and support continuous improvement of the CSV program.
Investigate and troubleshoot validation issues; lead root cause analysis and resolution of deviations.
Develop change controls and perform risk assessments for new and existing equipment or systems.
Support documentation development including validation plans, reports, policies (SOPs), and user requirement specifications.
Prepare, compile, and review validation packages and data for internal and external audits.
Collaborate with Engineering to ensure consistency in equipment and systems qualification.
Mentor and train staff on CSV procedures, practices, and compliance standards.
Maintain a comprehensive validation matrix and ensure equipment re-validation is scheduled and executed as required.
Participate in project management activities including project charters, scheduling (MS Project), client progress reviews, and performance reporting.
QualificationsEducation: Bachelor’s degree in Computer Engineering, Electrical Engineering, or Mechanical Engineering.
Experience: 3 to 5 years of hands-on CSV experience within the pharmaceutical or medical device industry.
Technical Skills:
Proficient in MS Office and computerized systems such as SAP, FactoryWorks, PC Servers, and Documentum.
Strong knowledge of FDA regulations and validation requirements (21 CFR Part 11, Part 820, and related CPGs).
Languages: Strong written and verbal communication skills in both English and Spanish.
Personal Attributes:
Strong documentation skills and attention to detail
Team player and self-starter with excellent communication and problem-solving abilities
Why Join Us?Opportunity to work in a regulated and innovation-driven environment
Collaborative team culture
Exposure to complex and impactful projects
Career development opportunities
