Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Project Coordinator – Downstream BiologicsProject Duration: 4–6 months, with potential for extension or future projects at the site.
Role Summary:
We are seeking a self-sufficient Project Coordinator to support a downstream biologics validation project at a cGMP manufacturing site. The ideal candidate has hands-on experience scheduling engineering activities across multiple departments and suppliers.
Key Responsibilities:
Coordinate project schedules, deliverables, and communications across multiple equipment vendors, validation service providers, and stakeholder departments.Develop and maintain daily, weekly, and monthly schedules. Tracks ongoing progress, identifies risks, and communicates clear status updates.Collaborate with Engineering, Manufacturing, Quality, and Automation teams to ensure activities are aligned, dependencies are managed, and timelines are maintainedAttends project update meetings as neededRequired Experience
Bachelor’s degree in Engineering, Life Sciences, or business administration.5+ years experience in project management.Ability to work on-site and operate independently.Excellent documentation and communication skills.Preferred:
Prior support of commercial manufacturing, technical transfer, or validation efforts.Availability for project start within short notice. Read LessValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Material Testing CoordinatorQualifications:
Bachelor's Degree in Science or Engineering.Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.Experience in direct process / manufacturing areas.Must be fully bilingual (English / Spanish) with excellent communication skills.Must be proficient using MS Windows and Microsoft Office applications.Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.Responsibilities
Confirmation of material quantities required for each of the project activities.Coordinate the request, dispatch and shipment of the material required. This may require coordination between the site and external/internal warehouses.Generate any documentation required.Review project / plant documentation.Comply with project schedule and escalate any roadblock or issues immediately including proposed mitigation plan.Provide support in other activities required.Available to work extended hours, possibility of weekends and holidays. Read LessValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Validation EngineerProject Duration: 4–6 months, with potential for extension or future projects at the site.
Role Summary:
We are seeking a self-sufficient Validation Engineer to support a downstream biologics validation project at a cGMP manufacturing site in Puerto Rico. The ideal candidate has hands-on experience validating downstream processes, equipment, and instruments and can manage validation activities with minimal supervision.
Key Responsibilities:
Execute and manage downstream validation activities (IQ/OQ/PQ, PPQ support).Validate downstream equipment including autoclaves, environmental chambers, chromatography, filtration/UF-DF, centrifuges, formulation systems, and lyophilizers.Validate analytical and process instruments (e.g., HPLC, in-line sensors).Author and execute validation protocols and reports in compliance with cGMP/FDA requirements.Collaborate with Engineering, Manufacturing, Quality, and Automation teams.Support deviations, change controls, and audit readiness as needed.Required Experience:
Bachelor’s degree in Engineering or Life Sciences.5+ years validation experience in biologics/pharmaceutical manufacturing.Strong hands-on experience with downstream process and equipment validation.Ability to work on-site and operate independently.Excellent documentation and communication skills.Preferred:
Prior support of commercial manufacturing or PPQ.Availability for project start within short notice. Read LessValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Specialist Quality ControlSUMMARY
Under general direction, functions as the technical specialist for testing and development in areas of molecular biology and microbiology. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources.
FUNCTIONS
EDUCATION
COMPETENCIES/SKILLS
ATRIBUTES:
Scientific Data Analysis.Strong Technical Writing (English and Spanish) mainly focuses.Strong knowledge in Microsoft Excel as a Tool for Data Analysis.Good Communication skills.Project Management.Knowledge in Computer System and Method Validation (Experience preferable).Strong knowledge and experience with quality process management.Basic Knowledge on equipment preventive maintenance and troubleshooting.Agile on prioritization of critical tasks.Ability to develop inspection or qualification protocols in a short timeframe period.Strong negotiation skills. Read LessValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Specialist Quality ControlSUMMARY
Under general direction, functions as the technical specialist for testing and development in areas of molecular biology and microbiology. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources.
FUNCTIONS
EDUCATION
COMPETENCIES/SKILLS
Validation & Engineering Group, Inc. (V&EG), a Pinnaql Company, is a leading professional services firm that provides engineering and regulatory compliance solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Talent Acquisition Specialist IThis is an on-site position at Guaynabo, PR.Description:
Handle hiring requests including:Collecting the hiring demands: Working alongside the Sales Department to finalize the hiring demands & JDs as well as fulfillment timeline.Job Description: Develop Job Descriptions in line with Human ResourcesRequisitions: Manage requisition entry into Applicant Tracking System (ATS)Job Postings: Post jobs via LinkedIn and other career sitesATS: Manage and update ATS as the source of truth for the talent acquisition processSourcing: Search for passive and active candidates and approach for the right opening jobs.Selection: phone interview, schedule interview, assign technical test, joining interview, prepare candidate assessment form, etc.Hiring Process: In conjunction with Human Resources, collaborate on the hiring process & progress to ensure good candidate experience.Offer: communicate verbal offer and collaborate with Human resources to prepare the offer, call the candidate to discuss the offer and relevant information, be prepared to negotiate during the process, if necessary, follow up with the candidate until the final decision is made, and update newcomer information on the portal.Maintain consistent communication with candidates throughout their candidacy process. Deliver updates including but not limited to rejection notification.Advertise jobs openings to attract candidates.Participate in job fairs to maintain a robust pool of candidates.Manage and exceed Talent Acquisition metrics and expectations developing relevant reports: weekly, monthly, and quarterly.Proactively build passive candidate pipeline to enlarge the Talent Pool.Qualifications:
Bachelor’s degree in human resources, related degree or equivalent work experience.At least 3 years of experience managing all phases of the recruitment and hiring process.At least 3 years of experience recruiting for the life sciences manufacturing industry (Pharma, Medical Devices or Biotechnology).At least 3 years of experience recruiting hourly professional consulting positions.At least 3 years of experience working with Excel, Word, Power Point, MS Outlook and Share Point.Experience working with Applicant Tracking Systems, preferably Clear Company.A high level of professionalism and discretion, this role will be have access to confidential employee data.A genuinely pro-active and helpful attitude, with a strong work ethic and excellent attention to details.Initiative and confidence to work autonomously when required.Ability to handle and effectively prioritize a diverse and changing workload.Strong communication skills with ability to speak to a wide range of people at all levels, including clients, company leadership, sales, and operations.Ability to work under pressure and in a fast-paced environment.Ability to quickly adapt to changes.Organization skills.Excellent verbal and written communication skills in both English and Spanish. Read LessValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Commissioning & Qualification (C&Q) ServicesFor: Class 5 Manufacturing Rooms. .ISO 14644 testingFor: Utilities and Facilities QualificationsTo Do: C&Q Plan, Risk Assessments, Traceability Matrices, DQ/IQ/OQ/PQ Protocols and ReportsQualifications:
Bachelor's Degree in Science or Engineering.Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.Must be fully bilingual (English / Spanish) with excellent oral skills.Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.Understanding of ASTM E2500 methodologies. Computer System Development Life Cycle (SDLC), Risk Assessment, Data Integrity.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays. Read LessValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Commissioning & Qualification (C&Q) ServicesFor: Class 5 Manufacturing Rooms. .ISO 14644 testingFor: Utilities and Facilities QualificationsTo Do: C&Q Plan, Risk Assessments, Traceability Matrices, DQ/IQ/OQ/PQ Protocols and ReportsQualifications:
Bachelor's Degree in Science or Engineering.Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.Must be fully bilingual (English / Spanish) with excellent oral skills.Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.Understanding of ASTM E2500 methodologies. Computer System Development Life Cycle (SDLC), Risk Assessment, Data Integrity.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays. Read LessValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Commissioning & Qualification (C&Q) ServicesFor: Class 5 Manufacturing Rooms. .ISO 14644 testingFor: Utilities and Facilities QualificationsTo Do: C&Q Plan, Risk Assessments, Traceability Matrices, DQ/IQ/OQ/PQ Protocols and ReportsQualifications:
Bachelor's Degree in Science or Engineering.Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.Must be fully bilingual (English / Spanish) with excellent oral skills.Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.Understanding of ASTM E2500 methodologies. Computer System Development Life Cycle (SDLC), Risk Assessment, Data Integrity.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays. Read LessValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Commissioning & Qualification (C&Q) ServicesFor: Class 5 Manufacturing Rooms. .ISO 14644 testingFor: Utilities and Facilities QualificationsTo Do: C&Q Plan, Risk Assessments, Traceability Matrices, DQ/IQ/OQ/PQ Protocols and ReportsQualifications:
Bachelor's Degree in Science or Engineering.Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.Must be fully bilingual (English / Spanish) with excellent oral skills.Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.Understanding of ASTM E2500 methodologies. Computer System Development Life Cycle (SDLC), Risk Assessment, Data Integrity.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays. Read Less