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Validation Project Manager Jobs in Puerto Rico (NOW HIRING)

Mirus Consulting Group

Project Manager - 35662

Juncos, PR · On-site

$100 - $125/hr

Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved. Position Summary The Project ...

FITS LLC

Project Manager

Manati, PR · On-site

... or validation departments. * Work under the direct supervision of project managers to complete ... design, engineering, and construction projects within schedule and budget constraints. * Generate ...

FITS LLC

Project Manager

Manati, PR · On-site

$60 - $80/hr

... or validation departments. * Work under the direct supervision of project managers to complete ... design, engineering, and construction projects within schedule and budget constraints. * Generate ...

Techengpr

Process Project Manager

Carolina, PR · On-site

$125 - $150/hr

... Validation, EHS, and external contractors. Key Responsibilities * Serve as the Owner ... Manage project scope, schedule, budget, risks, and change orders. * Develop project execution plans ...

Cotton

Construction Project Manager

Ponce, PR · On-site

$70K - $80K/yr

Construction Project Manager Department: Construction Employment Type: Full Time Location: Ponce ... Valid driver's license with a clean driving record. * Minimum of 21 years of age with at least 3 ...

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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

Validation Specialist

Validation & Engineering Group, Inc.

Aibonito, PR • On-site

Full-time

Posted 24 days ago

Key responsibilities

  • Develop, review, and execute validation master plans and validation protocols, including IQ, OQ, and PQ.

  • Validate and qualify equipment, facilities, utilities, cleanrooms, and other systems impacting product quality and safety.

  • Coordinate with cross-functional teams to ensure validation activities are completed according to project requirements.

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:
  • Validation Specialist

Key Responsibilities:
  • Develop, review, and execute Validation Master Plans (VMPs) and validation protocols, including IQ, OQ, and PQ.
  • Validate and qualify equipment, facilities, utilities, cleanrooms, and other systems that may impact medical-device safety and product quality.
  • Establish and maintain validation documentation, including protocols, reports, acceptance criteria, traceability, and stakeholder approvals.
  • Define and document validation roles, responsibilities, training, and competency requirements.
  • Maintain equipment inventories and support calibration, preventive maintenance, and qualification programs.
  • Support cleanroom and utility qualification activities, including environmental monitoring and trending.
  • Perform and document risk assessments, including FMEA, to identify and mitigate risks associated with equipment, processes, and systems.
  • Manage validation-related change controls, deviations, and CAPAs, ensuring appropriate investigation, documentation, and closure.
  • Coordinate with Engineering, Quality, Manufacturing, Facilities, Operations, and other stakeholders to ensure validation activities are completed according to project requirements.
  • Plan and coordinate resources, equipment availability, and required downtime to meet project milestones and schedules.
  • Obtain appropriate stakeholder review and sign-off for validation deliverables.
  • Support ongoing validation controls, including periodic requalification, continued monitoring, data trending, and management review.
  • Ensure validation activities remain compliant with applicable medical-device quality and regulatory requirements.
  • Identify potential compliance gaps and recommend corrective or preventive actions.

Required Qualifications
  • Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
  • Experience in validation and qualification within the medical device, pharmaceutical, biotechnology, or other regulated manufacturing environment.
  • Hands-on experience with IQ/OQ/PQ protocols and validation documentation.
  • Experience with risk management methodologies, including FMEA.
  • Knowledge of change control, deviations, CAPA, calibration, maintenance, and equipment qualification processes.
  • Experience working with facilities, utilities, cleanrooms, and/or environmental monitoring programs.
  • Strong understanding of Good Manufacturing Practices (GMP) and applicable quality requirements.
  • Strong technical writing, documentation, organizational, and project coordination skills.
  • Ability to work collaboratively with cross-functional teams and manage multiple validation activities simultaneously.

Preferred Qualifications:
  • Experience supporting medical device manufacturing and quality systems.
  • Familiarity with FDA and/or international medical-device regulatory requirements.
  • Experience with validation lifecycle management and periodic requalification programs.
  • Experience with electronic quality management or validation management systems.
  • Knowledge of process validation, computerized systems validation, or equipment automation is a plus.

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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