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Senior Validation Engineer Jobs in Puerto Rico (NOW HIRING)

CIS International LLC

PR

... Engineering department of a pharmaceutical manufacturing industry in Puerto Rico. Responsibilities: * Provide technical leadership for commissioning, qualification, and computer system validation ...

CIS International LLC

PR · On-site

... the Engineering department of a pharmaceutical manufacturing industry in Puerto Rico ... senior personnel. * Maintain validation documentation and ensure records are complete, accurate ...

Validation & Engineering Group, Inc

PR · On-site

We are seeking two experienced Validation Engineers (mid-level to senior) with strong expertise in utilities and facilities systems to support commissioning, qualification, and validation activities ...

Ultimate Solutions

Sr Scientist

Caguas, PR · On-site

$89K - $121K/yr

Description The successful Sr Validation Scientist will be responsible to Independently provide and/or direct the technical validation engineering support of process and/or equipment upgrades ...

Validation & Engineering Group, Inc

PR

$102K - $140K/yr

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer SUMMARY Independently provides and/or directs the ...

Validation & Engineering Group, Inc

PR · On-site

$102K - $140K/yr

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...

Validation & Engineering Group, Inc

PR · On-site

$102K - $140K/yr

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...

Pinnaql

Sr Engineer

Punta Santiago, PR · On-site

$103K - $142K/yr

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... following position: * Sr Engineer Description: Independently provides and/or directs the ...

Validation & Engineering Group, Inc

PR · On-site

$89K - $122K/yr

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Process Development Sr Scientist Education: * Doctorate PhD OR PharmD OR MD * OR -Master + 3 years ...

Quality Consulting Group

JT627 - SR ENGINEER

Juncos, PR · On-site

$102K - $140K/yr

Knowledge in Validation & Engineer Project * Experience in Medical Devices o Pharmaceutical ... Administrative Shift: 8:00 AM - 5:00 PM | Overtime may be required based on business needs. Quality ...

Validation & Engineering Group, Inc

PR · On-site

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Senior Quality Analyst Qualifications: * Bachelors degree in Biotechnology, Biology, Chemistry or ...

New

Validation & Engineering Group, Inc

PR

$89K - $122K/yr

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Process Development Sr Scientist Education: * Doctorate (PhD, PharmD, or MD) with relevant ...

Validation & Engineering Group, Inc

PR · On-site

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... * Sr Associate EH&S Education: * Master degree or Bachelor degree & 2 years of directly related ...

Inteldot

Sr Manufacturing Engineer

Dorado, PR · On-site

$80K - $109K/yr

Employment type: Full time and onsite role Role Summary The Senior Manufacturing Engineer provides ... Lead equipment and process validation activities (IQ/OQ/PQ), including validation strategy ...

Validation & Engineering Group, Inc

PR

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Alert senior management of quality, compliance, supply, and safety risks. * Provide support and ...

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Senior Validation Engineer information

What does a senior validation engineer do?

A Senior Validation Engineer is responsible for ensuring that products, systems, or processes meet regulatory standards and function as intended. They develop and execute validation protocols, analyze test data, and document results to confirm compliance with industry and company standards. Senior Validation Engineers often lead validation projects, collaborate with cross-functional teams, and mentor junior staff. Their work is critical in industries like pharmaceuticals, biotechnology, and manufacturing, where product safety and efficacy are essential.

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

To thrive as a Senior Validation Engineer, you need a solid background in engineering, quality assurance, and regulatory compliance, typically supported by a relevant degree and experience in validation within regulated industries. Familiarity with validation protocols (IQ, OQ, PQ), statistical analysis tools, and systems like FDA 21 CFR Part 11 is crucial. Strong problem-solving, attention to detail, and effective communication skills help ensure successful project outcomes and cross-functional collaboration. These skills and qualifications are essential to maintain product quality, meet regulatory standards, and drive continuous improvement.

What are some typical challenges faced by senior validation engineers when leading validation projects?

Senior Validation Engineers often encounter challenges such as managing tight project timelines, ensuring compliance with evolving regulatory standards, and coordinating cross-functional teams. Balancing the needs of production, quality assurance, and regulatory affairs requires strong communication and project management skills. Additionally, troubleshooting unexpected validation failures and documenting results thoroughly are key aspects that demand both technical expertise and attention to detail.

What is the difference between Senior Validation Engineer vs Validation Specialist?

AspectSenior Validation EngineerValidation Specialist
CredentialsBachelor's or Master's in Engineering, Life Sciences, or related fields; often with certifications like GxP or CSVSimilar educational background; certifications like GxP or CSV are common
Work EnvironmentDesigns and oversees validation protocols in manufacturing, biotech, or pharmaceutical settingsExecutes validation tasks, tests, and documentation in similar environments
Employer & IndustryPharmaceutical, biotech, medical device companiesSame industries, often working under validation teams
Search & ComparisonOften compared for experience level and responsibilitiesCommonly searched together for validation roles

The main difference is that a Senior Validation Engineer typically leads validation projects, designs protocols, and oversees validation activities, while a Validation Specialist focuses on executing validation tests and documentation. Both roles require similar credentials and work in comparable environments, but the Senior Validation Engineer has more responsibility for planning and oversight.

What are the most commonly searched types of Validation Engineer jobs in Puerto Rico?

The most popular types of Validation Engineer jobs in Puerto Rico are:

What are popular job titles related to Senior Validation Engineer jobs in Puerto Rico?

For Senior Validation Engineer jobs in Puerto Rico, the most frequently searched job titles are:

What job categories do people searching Senior Validation Engineer jobs in Puerto Rico look for?

The top searched job categories for Senior Validation Engineer jobs in Puerto Rico are:

What cities in Puerto Rico are hiring for Senior Validation Engineer jobs?

Cities in Puerto Rico with the most Senior Validation Engineer job openings:

What are popular job titles related to Senior Validation Engineer jobs in PR?

For Senior Validation Engineer jobs in PR, the most frequently searched job titles are:

Senior Validation Engineer jobs near you

Sr. Qualification & Validation Engineer - capital projects

CIS International LLC

PR

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.
  • 7-10 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: 3
  • Administrative shift, wiling to support non-admin hours