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Validation Project Manager Jobs in Puerto Rico (NOW HIRING)

Pinnaql

CQV Project Manager

Juncos, PR · On-site

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... CQV Project Manager Job Summary: We are seeking an experienced CQV Project Manager to lead the ...

FITS LLC

Sr Project Mgr- Validation

Juncos, PR · On-site

$100 - $125/hr

Project Management skills. * Shift: Administrative and according to business needs. * Experience in: * Process validation and qualifications. * Change control management, project controls and capital ...

New

FITS LLC

Sr Project Mgr- Validation

Juncos, PR · On-site

Project Management skills. * Shift: Administrative and according to business needs. * Experience in: * Process validation and qualifications. * Change control management, project controls and capital ...

New

Veg Group

CQV Project Manager

Juncos, PR · On-site

$125 - $150/hr

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... CQV Project Manager Job Summary: We are seeking an experienced CQV Project Manager to lead the ...

New

HR Works

Validation / CSV Specialist

Las Piedras, PR · On-site

$60 - $80/hr

Utilize Kneat to create, manage, execute, route, and maintain validation documents and records ... Participate in validation project meetings and provide updates regarding assigned activities ...

HR-Work

Validation / CSV Specialist

Las Piedras, PR · On-site

$60 - $80/hr

Utilize Kneat to create, manage, execute, route, and maintain validation documents and records ... Participate in validation project meetings and provide updates regarding assigned activities ...

Pinnaql

Project Manager

Manati, PR · On-site

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 ...

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Validation Project Manager information

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.

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 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:

Validation Project Manager jobs near you

CQV Project Manager

Validation & Engineering Group, Inc.

Juncos, PR • On-site

Full-time

Posted 4 days ago

Job description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company 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:
  • CQV Project Manager

Job Summary:
We are seeking an experienced CQV Project Manager to lead the project team supporting the Repatha P5.0 cleaning characterization and sterilization qualification program at a biologics manufacturing facility in Juncos, Puerto Rico.
The Project Manager will serve as Pinnaql's primary project representative and will be responsible for staffing, schedule, cost, execution coordination, progress reporting, risk management, and overall delivery of the contracted CQV scope.
Key Responsibilities
  • Lead the overall Pinnaql CQV project team and serve as the primary interface with the client Project Verification Lead.
  • Coordinate Technical Leads and CQV resources supporting cleaning and sterilization workstreams.
  • Develop and maintain the detailed project execution schedule and staffing plan.
  • Track actual staffing and project spending against the approved plan.
  • Provide weekly progress reporting including:
    • Cost versus plan
    • Forecast cost to complete
    • Document preparation plan versus actual
    • Execution plan versus actual
    • Key risks and recovery actions
  • Monitor protocol development, execution, reporting, and approval milestones.
  • Coordinate workload and resource assignments to meet project priorities.
  • Manage staffing requirements for critical 7-day/24-hour execution periods.
  • Facilitate coordination meetings with Manufacturing, Engineering, Quality, QC, EHS, and other stakeholders as required.
  • Ensure meeting minutes and action items are documented and tracked.
  • Identify schedule, resource, cost, and execution risks.
  • Develop mitigation and remediation plans when delays or cost overruns are predicted.
  • Ensure project documentation and reports progress through the required review and approval process.
  • Maintain team continuity and manage contractor performance.
  • Ensure project execution complies with client GMP, safety, and administrative requirements.

Required Qualifications
  • Bachelor's degree in Engineering, Science, Project Management, or related technical discipline.
  • Significant experience managing CQV or validation projects in pharmaceutical or biotechnology manufacturing.
  • Demonstrated experience managing multidisciplinary technical teams.
  • Strong understanding of GMP project execution.
  • Experience managing project schedules, resources, costs, forecasts, and project metrics.
  • Proven experience successfully delivering projects of similar complexity and scale.
  • Strong communication, leadership, and client-management skills.

Preferred Qualifications
  • Experience managing cleaning validation and/or sterilization qualification programs.
  • Biologics drug-substance manufacturing experience.
  • Previous Amgen project experience.
  • Experience with Smartsheet or similar project-management platforms.
  • Familiarity with Kneat, LIMS, OSI PI, MAXIMO, and client LMS systems.

Schedule
Overall project support is anticipated from approximately October 2026 through May 2027, with significant execution activity between December 2026 and March 2027.
At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

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