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Senior Validation Engineer Jobs in Puerto Rico (NOW HIRING)

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

Senior Engineer Location: Juncos, Puerto Rico Eligibility: Open to Puerto Rico Residents Number of ... Knowledge of equipment characterization and validation processes. * Experience with vision systems ...

Senior Engineer-35381

Juncos, PR

$101K - $139K/yr

SENIOR ENGINEER Location: Onsite - Puerto Rico Duration: 6 Months Position Summary The Senior ... Validation, Utilities, Facilities, and Maintenance teams to support business objectives. • ...

Sr Engineer - 35381

Juncos, PR

$101K - $139K/yr

Its services include the assessment and validation of automation equipment, network infrastructures ... Position Summary The Senior Engineer is responsible for providing advanced engineering support to ...

Sr Engineer - 35381

Juncos, PR · On-site

$101K - $139K/yr

Its services include the assessment and validation of automation equipment, network infrastructures ... Position Summary The Senior Engineer is responsible for providing advanced engineering support to ...

Sr Engineer - 35381

Juncos, PR

$101K - $139K/yr

Its services include the assessment and validation of automation equipment, network infrastructures ... Position Summary The Senior Engineer is responsible for providing advanced engineering support to ...

Sr Engineer - 35354

Juncos, PR

$101K - $139K/yr

Its services include the assessment and validation of automation equipment, network infrastructures ... Position Summary The Senior Engineer is responsible for leading and supporting engineering ...

Sr Engineer - 35354

Juncos, PR

$101K - $139K/yr

Its services include the assessment and validation of automation equipment, network infrastructures ... Position Summary The Senior Engineer is responsible for leading and supporting engineering ...

Sr Engineer - 35354

Juncos, PR · On-site

$101K - $139K/yr

Its services include the assessment and validation of automation equipment, network infrastructures ... Position Summary The Senior Engineer is responsible for leading and supporting engineering ...

Sr Engineer

Juncos, PR

$102K - $140K/yr

... in the validation and regulatory fields. Log on now to our website qrcgroup.com / to learn more ... and solutions! Sr Engineer with experience in Manufacturing Operations Hands-on experience in ...

Sr. Engineer

Juncos, PR

$102K - $140K/yr

We are looking for a visionary Sr. Engineer to lead complex projects, mentor top-tier talent, and ... Working knowledge of pharmaceutical/biotech processes Familiarity with validation processes ...

Sr Engineer - 35404

Juncos, PR

$101K - $139K/yr

Its services include the assessment and validation of automation equipment, network infrastructures ... Position Summary The Senior Engineer is responsible for providing the characterization of process ...

Sr Engineer - 35404

Juncos, PR

$101K - $139K/yr

Its services include the assessment and validation of automation equipment, network infrastructures ... Position Summary The Senior Engineer is responsible for providing the characterization of process ...

Sr Engineer - 35404

Juncos, PR · On-site

$101K - $139K/yr

Its services include the assessment and validation of automation equipment, network infrastructures ... Position Summary The Senior Engineer is responsible for providing the characterization of process ...

Sr. Engineer

Juncos, PR · On-site

$102K - $140K/yr

We are looking for a visionary Sr. Engineer to lead complex projects, mentor top-tier talent, and ... Preferred experience in Packaging Area Knowledge in equipment characterization/validation, Vision ...

PR

$102K - $140K/yr

We are looking for a visionary Sr. Engineer to lead complex projects, mentor top-tier talent, and ... Preferred experience in Packaging Area Knowledge in equipment characterization/validation, Vision ...

Sr. Engineer

Juncos, PR

$102K - $140K/yr

We are looking for a visionary Sr. Engineer to lead complex projects, mentor top-tier talent, and ... Preferred experience in Packaging Area Knowledge in equipment characterization/validation, Vision ...

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Senior Validation Engineer information

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 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 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:

Environmental Monitoring Performance Qualification (EMPQ) Scientist

Validation & Engineering Group Inc.

Punta Santiago, PR

$74K - $97K/yr

Other

Posted yesterday


Job description

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:

  • Environmental Monitoring Performance Qualification (EMPQ) - Sr CQV Scientist
    • Evaluate project change control and confirm EM PQ scope of work.

    • Generate Validation Plan (VP).

    • Develop and execute EM PQ protocols.

    • Develop EM PQ reports for applicable systems.

    • Pursue project deliverables.

Qualifications:

  • Bachelor's Degree in Science or Engineering.
  • Minimum of 5 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.
  • Solid experience performing Environmental Monitoring Performance Qualification (EMPQ).
    • Sampling Plan strategy and data analysis of results
  • Experience with Commissioning, Qualification and Validation (CQV).
  • Solid experience in the development of Risk Assessments.
  • Practical knowledge developing and executing Computer System Life Cycle (SDLC) documents. i.e. VP, URS, FDS, RA, IOPQ, TMX, and Reports.
  • Technical Writing skills and investigations processes.
  • Available to work extended hours, possibility of weekends and holidays.