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Validation Project Manager Jobs in Puerto Rico (NOW HIRING)

PR · On-site

... management of facilities, utilities, manufacturing equipment, process systems, and computerized systems. * Planning, coordinating, and delivering qualification and validation project milestones ...

... management of facilities, utilities, manufacturing equipment, process systems, and computerized systems. * Planning, coordinating, and delivering qualification and validation project milestones ...

PR · On-site

Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethical ...

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Project Manager Position Summary The Project Manager will lead and support a portfolio of capital ...

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Project Manager Position Summary The Project Manager will lead and support a portfolio of capital ...

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Project Manager Position Summary The Project Manager will lead and support a portfolio of capital ...

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Project Manager Position Summary The Project Manager will lead and support a portfolio of capital ...

PR · On-site

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Project Manager Position Summary The Project Manager will lead and support a portfolio of capital ...

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Project Manager (Civil, Structural and Architectural) Responsibilities: Project Oversight Owners ...

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Project Manager Description: We are looking for a dedicated Project Manager with a strong ...

PR · On-site

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Design Lead/Design Project Manager Responsibilities: * Lead in the identification of the applicable ...

PR · On-site

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Design Lead/Design Project Manager Responsibilities: * Lead in the identification of the applicable ...

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Design Lead/Design Project Manager Responsibilities: * Lead in the identification of the applicable ...

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Design Lead/Design Project Manager Responsibilities: * Lead in the identification of the applicable ...

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Design Lead/Design Project Manager Responsibilities: * Lead in the identification of the applicable ...

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Design Lead/Design Project Manager Responsibilities: * Lead in the identification of the applicable ...

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Design Lead/Design Project Manager Responsibilities: * Lead in the identification of the applicable ...

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Design Lead/Design Project Manager Responsibilities: * Lead in the identification of the applicable ...

PR · On-site

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Design Lead/Design Project Manager Responsibilities: * Lead in the identification of the applicable ...

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Validation Project Manager information

How does a validation project manager typically collaborate with cross-functional teams during a project?

A Validation Project Manager regularly collaborates with cross-functional teams such as quality assurance, regulatory affairs, engineering, and production to ensure that all validation activities meet regulatory standards and project timelines. This collaboration often involves coordinating meetings, aligning on project milestones, and facilitating clear communication to address any technical or compliance issues. Building strong working relationships across departments is crucial for anticipating challenges and ensuring a smooth validation process. Effective coordination helps to minimize delays and ensures that all documentation and testing requirements are thoroughly met.

What are the key skills and qualifications needed to thrive as a validation project manager, and why are they important?

To thrive as a Validation Project Manager, you need expertise in regulatory compliance, project management, and validation protocols, often supported by a degree in engineering, life sciences, or a related field. Familiarity with validation software, quality management systems (QMS), and certifications like PMP or Six Sigma are commonly required. Exceptional organizational, leadership, and communication skills help coordinate cross-functional teams and manage complex timelines. These skills are crucial to ensure validated processes comply with industry standards, mitigate risks, and deliver successful project outcomes.

What is a validation project manager?

A Validation Project Manager is a professional responsible for overseeing and coordinating validation activities in industries such as pharmaceuticals, biotechnology, or manufacturing. Their main duties include ensuring that systems, equipment, and processes meet regulatory standards and operate as intended. They manage project timelines, resources, and communication among cross-functional teams to ensure successful validation outcomes. Additionally, they maintain documentation and ensure compliance with industry regulations such as FDA or GMP. This role is crucial for maintaining product quality, safety, and regulatory compliance.

What is the difference between Validation Project Manager vs Quality Assurance Specialist?

AspectValidation Project ManagerQuality Assurance Specialist
CertificationsGMP, ISO, PMPISO, Six Sigma, GMP
Work EnvironmentRegulated industries like pharma, biotechManufacturing, software, healthcare
Primary FocusEnsuring validation processes and protocolsMaintaining quality standards and procedures
Employer UsagePharmaceutical, biotech, medical device companiesManufacturers, software firms, healthcare providers

The Validation Project Manager primarily oversees validation activities, ensuring compliance with industry standards, while the Quality Assurance Specialist focuses on maintaining overall quality standards across processes. Both roles require similar certifications and are common in regulated industries, but their core responsibilities differ in scope and focus.

What are popular job titles related to Validation Project Manager jobs in Puerto Rico?

For Validation Project Manager jobs in Puerto Rico, the most frequently searched job titles are:

What job categories do people searching Validation Project Manager jobs in Puerto Rico look for?

The top searched job categories for Validation Project Manager jobs in Puerto Rico are:

What cities in Puerto Rico are hiring for Validation Project Manager jobs?

Cities in Puerto Rico with the most Validation Project Manager job openings:

Qualification & Validation Engineer II - capital projects

CIS International LLC

PR • On-site

Full-time, Contractor

Posted 17 days ago


Job description

Summary:
Commissioning and Qualification (C&Q) contracted services to support capital projects for the Engineering department of a pharmaceutical manufacturing industry in Puerto Rico.
Responsibilities:
  • Provide technical leadership for commissioning, qualification, and computer system validation activities, including:
    • Leading and executing end-to-end qualification and lifecycle management of facilities, utilities, manufacturing equipment, process systems, and computerized systems.
    • Planning, coordinating, and delivering qualification and validation project milestones within scope, timeline, and budget constraints.
    • Developing, reviewing, approving, and executing validation lifecycle documentation, including Validation Master Plans, User Requirements Specifications (URS), Functional and Design Specifications, Risk Assessments, Commissioning Plans, IQ/OQ/PQ protocols, and summary reports.
    • Directing protocol execution activities, including data collection, field sampling, data trending, statistical analysis, deviation assessment, root cause investigations, and implementation of corrective actions.
    • Monitoring, tracking, and communicating validation project status, risks, and deliverables to project teams and leadership.
  • Develop and scientifically justify validation strategies, acceptance criteria, sampling plans, and protocol designs based on risk management principles, process understanding, and industry best practices.
  • Evaluate and document the impact of change controls on qualified systems, validated processes, facilities, utilities, and computerized systems, ensuring compliance with site and regulatory requirements.
  • Lead and support investigations, deviations, and CAPAs, providing technical expertise to resolve complex quality, validation, and manufacturing issues.
  • Develop, implement, and continuously improve validation procedures, standards, policies, and lifecycle management practices aligned with regulatory expectations and industry trends.
  • Maintain compliance with current global regulatory requirements and industry guidance, including but not limited to:
    • 21 CFR Parts 210, 211, and 11
    • EU GMP Annex 11 and Annex 15
    • ICH Q8, Q9, and Q10
    • ISPE Baseline Guides and GAMP 5
    • Applicable domestic and international regulatory standards
  • Manage multiple high-priority projects simultaneously, balancing competing demands while consistently meeting aggressive timelines and business objectives.
  • Perform other duties and special projects as assigned.
Requirements:
  • Bachelor's degree in Engineering, Biology, Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
  • 3-5 years’ experience in pharmaceutical or regulated manufacturing environment; ideally, the candidate will have previous Oral Solid Dose (OSD) manufacturing experience.
Work Methodology:
  • Professional services agreement (independent contractor)
  • Full time job
  • Full on site job in Vega Baja, Puerto Rico
  • Languages: Spanish and English
  • Type of industry: Pharmaceutical
  • Expected hiring date:  August 2026
  • Project term: 6-12 months with potential extensions
  • Amount of openings: 4
  • Administrative shift, wiling to support non-admin hours