Location: On-site [JUNCOS, GURABO AREA]
This is a contract-based opportunity for an independent professional willing to work at client site.
Duration: 6 months with possible extension.
Needs to be immediately available.
Job Description:
We are seeking a Project Coordinator with strong EHS experience to support a pharmaceutical facility shutdown and related facilities improvement projects. This role will be 100% on-site and focused on planning, coordination, and safe execution of activities in a GMP-regulated environment.
The ideal candidate has hands-on experience in pharma or other highly regulated industries, understands EHS requirements (safety permits, contractor safety, LOTO, confined space, etc.), and is comfortable coordinating multiple internal and external stakeholders during a shutdown period.
Main responsibilities:
Project Coordination & PlanningSupport planning and execution of facility shutdown projects, including maintenance, repairs, construction, equipment coalification, and facility improvements.Develop and maintain project schedules, task lists, and look-ahead plans for shutdown activities.Coordinate daily activities with Operations, Engineering, Maintenance, EHS, Quality, and external contractors.Track project milestones, deliverables, and issues, escalating risks or delays as needed.Assist with preparation and coordination of work permits, shutdown plans, and readiness checklists.EHS & ComplianceEnsure all shutdown and facilities improvement activities comply with EHS standards, site safety policies, and GMP requirements.Support implementation and monitoring of Job Safety Analyses (JSA), Risk Assessments, and Safe Work Permits (hot work, confined space, LOTO, working at heights, etc.).Participate in daily toolbox talks / pre-job briefings and help reinforce safety expectations with contractors and internal staff.Coordinate incident reporting, near-miss documentation, and follow-up on corrective and preventive actions.Support audits, walkthroughs, and inspections during shutdown to verify adherence to EHS and GMP standards.Documentation & GMP SupportEnsure proper documentation of shutdown activities in alignment with GMP and site procedures.Coordinate approvals of work plans, deviations, and change controls as required by Quality and Engineering.Maintain accurate project records: permits, logs, attendance sheets, meeting minutes, and progress reports.Support preparation of closeout documentation, including punch lists, lessons learned, and final reports.Stakeholder CommunicationServe as a day-to-day point of contact for shutdown coordination between internal teams and contractors.Organize and facilitate coordination meetings, daily shutdown huddles, and status update sessions.Prepare and distribute concise status updates, dashboards, and progress summaries to stakeholders.
General requirements:
Knowledge of OSHA and relevant local EHS regulations.Strong understanding of basic GMP principles and documentation practices.Proficiency with MS Office / project tracking tools (Excel, Word, PowerPoint; basic scheduling tools).Strong organizational, communication, and follow-up skills; comfortable coordinating multiple tasks and stakeholders.Ability to work 100% on-site, including during critical shutdown periods and potential extended hours or weekends as needed.Education Requirements:
Bachelor’s degree in Engineering, Industrial Management, or related field A combination of education and relevant experience can be considered.Experience Requirements:
Minimum 2 years of experience in project coordination, facilities, or maintenance role in a GMP-regulated environment (pharmaceutical, biotech, medical device, or similar).Demonstrated experience supporting EHS activities (safety programs, permits, JSAs, incident reporting, contractor safety, etc.).Proven experience working with facility improvement projects.
Preferred Requirements:
Fluent in Spanish and English (spoken and written).Experience in pharmaceutical sites shutdowns.Training or certification in EHS, OSHA 30, or similar.Basic experience with project management tools (e.g., MS Project, Primavera, or similar).
Personal Attributes:
Strong attention to detail and a disciplined, safety-first mindset.Proactive, solution-oriented, and able to work under time pressure.Comfortable interacting with technicians, engineers, managers, and external contractors.High sense of responsibility, reliability, and professional ethics. Read LessLOCATION: On Site (San Lorenzo, Gurabo, Juncos, Las Piedras), Puerto Rico
We are seeking an experienced Project Manager with solid experience leading minor construction and facility improvement projects in the pharmaceutical or life sciences industry, including painting, door installations, HVAC systems, and infrastructure upgrades. This is a contract-based opportunity for an independent contractor professional with expertise in coordinating with personnel responsible for manufacturing areas to plan and execute tasks without impacting production or regulatory compliance. Experience managing projects in regulated environments is required, ensuring compliance with regulations and Quality Management Systems (QMS). Additionally, the independent contractor should possess strong problem-solving skills, proposing viable solutions to overcome operational constraints. Effective communication with multidisciplinary teams such as engineering, maintenance, manufacturing, and quality is essential to ensure projects are completed safely, efficiently, on time, and within budget.
Main Responsibilities:
Lead and oversee minor construction and facility improvement projects within the pharmaceutical environment.Coordinate with manufacturing, engineering, maintenance, and quality personnel to ensure proper execution of tasks.Coordinate and monitor projects through the entire project lifecycle.Develop, manage, and monitor project schedule and project budget.Ensure that all project activities are delivered on time, within scope, within budget, and in compliance with safety requirements.Identify risks and obstacles during execution and implement mitigation actions to minimize impacts.Perform risk management to minimize project risks.Ensure compliance with applicable regulatory and quality standards.Provide effective and timely communications with stakeholders and report progress to management.Promote best practices and continuous improvement in project management processes.General Requirements:
Bilingual (Spanish and English)Proficiency in Microsoft Office 365 (Project, Excel, Word, Power Point)PMP or LPP certifications highly preferredTravel Requirements:
Depending on the assigned project may be required to travel 0-10% of the time.Education Requirements:
Bachelor’s degree in Business, Engineering, Project Management, or related field or a combination of education and experience.Experience Requirements:
8+ year experience leading construction and facility improvement projects in the pharmaceutical or life sciences industry.Knowledge of regulatory requirements (FDA, cGMP) and Quality Management Systems (QMS).Experience coordinating with manufacturing teams to plan activities.Experience with budget development and monitoring preferred.Skills:
Strong problem-solving skills and ability to make decisions under pressure.Excellent verbal and written communication skills, capable of interacting with multidisciplinary teams.Ability to manage multiple projects simultaneously, meeting deadlines and budgets.Proactive, detail-oriented, and safety-focused. Read LessLOCATION: Las Piedras / Gurabo / Juncos
We are seeking a Commissioning & Qualification Specialist to support a pharmaceutical manufacturing facility in the central/East area of Puerto Rico. The specialist will be responsible for conducting qualification activities of equipment, utilities, and facilities to ensure they comply with installation and operations requirements and regulatory standards. This is a contract-based opportunity for an independent professional willing to work at client site.
Main Responsibilities:
Develop and execute qualification protocols (Commissioning, IQ, OQ, PQ) for pharmaceutical equipment and facilities. Ensure qualification and validation activities meet company procedures and regulatory requirements.Manage Change Controls by initiating or reviewing for approval prior to execution, tracking associated tasks to ensure timely completion, and documenting closure in full compliance with FDA regulations, cGMP requirements, and company quality system procedures.Perform installation and operational checks for pharmaceutical equipment and systems. Develop commissioning protocols and execute commissioning activities for new or upgraded systems. Identify and resolve technical issues during qualification activities.Create and maintain accurate and complete documentation, including protocols, test scripts, reports, and SOPs. Ensure traceability of all qualification and validation activities.Ensure compliance with global regulatory standards (e.g., FDA, ICH, etc.) and industry guidelines.Support the periodic review and requalification of pharmaceutical systems. Coordinate system upgrades, decommissioning, and troubleshooting.Partner with QC, validation, IT, and engineering teams to ensure seamless implementation. Provide support during regulatory audits and inspections.General Requirements:
Fluent in Spanish and English (spoken and written).Proficiency in Microsoft Office 365 (Teams, SharePoint, Outlook, Excel, Word, PowerPoint) and project management tools.Proficiency in documentation practices and attention to detail. Effective communication skills and ability to present complex technical information to diverse audiences.Excellent problem-solving skills and ability to work collaboratively in a cross-functional team environment.Excellent communication skills.Education Requirements:
Bachelor’s Degree in engineering, life sciences or other related fields.Experience Requirements:
3+ years qualifying facilities and equipment in the Pharmaceutical Industry.In-depth knowledge of regulatory requirements (e.g., cGMP, FDA) related to commissioning, qualification, and validation activities.Strong understanding of equipment and facility qualification, risk assessments, and validation principles.Experience in conducting investigations, particularly related to deviations, and familiarity with Corrective and Preventive Action (CAPA) processes.Physical Requirements:
Ability to sit for long periods.Light physical activity may be required occasionally.Must be able to visit field locations as needed.Must be able to use personal protective equipment (PPE) when required.Ability to perform in a variety of industrial environments. Read Less