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Senior Validation Engineer Jobs in Humacao, PR (NOW HIRING)

Mirus Consulting Group

Sr Engineer - 35600

Juncos, PR · On-site

$101K - $139K/yr

Its services include the assessment and validation of automation equipment, network infrastructures ... Position Summary We are seeking a highly motivated Senior Engineer to provide technical expertise ...

Amgen, Inc.

Senior Engineer

Juncos, PR · On-site

$101K - $139K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Senior Engineer What you will do Let's do this. Let's change the world. In this vital role you will ... Familiarity with Quality Management Systems (QMS), including validation, deviations, and CAPA ...

Mirus Consulting Group

Sr Engineer - 35409

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 ...

Mirus Consulting Group

Sr Engineer - 35600

Juncos, PR

$101K - $139K/yr

Its services include the assessment and validation of automation equipment, network infrastructures ... Position Summary We are seeking a highly motivated Senior Engineer to provide technical expertise ...

Amgen Inc

Senior Engineer

Juncos, PR · On-site

$101K - $139K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Senior Engineer What you will do Let's do this. Let's change the world. In this vital role you will ... Familiarity with Quality Management Systems (QMS), including validation, deviations, and CAPA ...

Amgen

Senior Engineer

Juncos, PR

$101K - $139K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Senior Engineer What you will do Let's do this. Let's change the world. In this vital role you will ... Familiarity with Quality Management Systems (QMS), including validation, deviations, and CAPA ...

Baxter

Sr. Engineer, Packaging

Guayama, PR · On-site

  • Medical

  • Dental

  • Life

  • Retirement

  • PTO

As a Senior Engineer - Packaging, you will partner closely with Manufacturing, Quality, Maintenance, Validation, Supply Chain, and Site Engineering teams to drive operational excellence across ...

Baxter Healthcare

Sr. Engineer, Packaging

Guayama, PR · On-site

  • Medical

  • Dental

  • Life

  • Retirement

  • PTO

As a Senior Engineer - Packaging, you will partner closely with Manufacturing, Quality, Maintenance, Validation, Supply Chain, and Site Engineering teams to drive operational excellence across ...

Weil Group, Inc.

Sr Quality Engineer

Humacao, PR · On-site +1

$89K - $121K/yr

Knowledge of validation and manufacturing processes, including equipment, process, product, and ... Engineering bachelor degree + 4 years experience **Weil Group is proud to be an Equal Employment ...

Weil Group, Inc

Sr Quality Engineer

Humacao, PR

$89K - $121K/yr

Knowledge of validation and manufacturing processes, including equipment, process, product, and ... Engineering bachelor degree + 4 years experience **Weil Group is proud to be an Equal Employment ...

Medtronic

Sr Quality Engineer

Humacao, PR · On-site

$89K - $121K/yr

The Sr. Quality Engineer supports quality assurance activities within a regulated manufacturing ... Knowledge of validation concepts for equipment, processes, products, and software, including URS ...

Medtronic

Sr Quality Engineer

Humacao, PR · On-site

$89K - $121K/yr

The Sr. Quality Engineer supports quality assurance activities within a regulated manufacturing ... Knowledge of validation concepts for equipment, processes, products, and software, including URS ...

Medtronic

Sr Quality Engineer

Humacao, PR · On-site

$89K - $121K/yr

The Sr. Quality Engineer supports quality assurance activities within a regulated manufacturing ... Knowledge of validation concepts for equipment, processes, products, and software, including URS ...

Weil Group, Inc.

Sr. Engineer

Juncos, PR · On-site +1

$102K - $140K/yr

... validation departments in developing requirements and recommendations for large and/or highly ... engineering projects within schedule, budget and quality constraints. 4. Coordinate the work of ...

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Showing results 21-40

All JobsValidation Engineer JobsSenior Validation Engineer JobsSenior Validation Engineer Jobs in Humacao, PR

Senior Validation Engineer information

See Humacao, PR salary details

$35

$65

$100

How much do senior validation engineer jobs pay per hour?

As of Aug 17, 2026, the average hourly pay for senior validation engineer in Humacao, PR is $65.58, according to ZipRecruiter salary data. Most workers in this role earn between $52.31 and $74.47 per hour, depending on experience, location, and employer.

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 cities near Humacao, PR are hiring for Senior Validation Engineer jobs?

Cities near Humacao, PR with the most Senior Validation Engineer job openings:

Senior Validation Engineer jobs near you
Infographic showing various Senior Validation Engineer job openings in Humacao, PR as of August 2026, with employment types broken down into 87% Full Time, 4% Part Time, 3% Temporary, and 6% Contract. Highlights an 89% Physical, 4% Hybrid, and 7% Remote job distribution, with an average salary of $136,409 per year, or $65.6 per hour.

Sr Engineer - 35600

Mirus Consulting Group

Juncos, PR • On-site

$101K - $139K/yr

Full-time

Posted 5 days ago

Job description

mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.
Position Summary
We are seeking a highly motivated Senior Engineer to provide technical expertise and leadership in support of equipment assessments and engineering evaluations within a regulated pharmaceutical or biotechnology manufacturing environment. This role is responsible for conducting comprehensive technical assessments, evaluating equipment performance and reliability, supporting quality systems activities, and ensuring equipment remains fit for its intended use while maintaining compliance with cGMP requirements.
Key Responsibilities
  • Perform technical assessments of manufacturing equipment to evaluate performance, reliability, operational suitability, and continued fitness for intended use.
  • Prepare, review, and approve technical reports, engineering assessments, equipment evaluations, technical justifications, and supporting documentation.
  • Evaluate equipment failures, recurring performance issues, maintenance history, operating conditions, and their potential impact on product quality, process performance, equipment qualified state, and regulatory compliance.
  • Provide engineering support for deviations, investigations, Corrective and Preventive Actions (CAPAs), change controls, risk assessments, and post-FDA commitment activities.
  • Assess equipment design, functionality, lifecycle documentation, maintenance strategies, and long-term reliability to support informed technical decision-making.
  • Review and interpret engineering drawings, technical specifications, vendor documentation, equipment manuals, work orders, calibration records, maintenance records, and historical performance data.
  • Develop scientifically sound, data-driven conclusions and recommendations supported by objective evidence and documented rationale.
  • Collaborate effectively with Manufacturing, Maintenance, Automation, Validation, Quality Assurance, Process Development, and external vendors to gather, analyze, and evaluate technical information.
  • Ensure technical assessments are complete, traceable, inspection-ready, and compliant with applicable regulatory and internal quality requirements.
  • Support continuous improvement initiatives to enhance equipment reliability, operational performance, and compliance.
  • Maintain a strong field presence by inspecting equipment, verifying actual operating conditions, and confirming technical observations within manufacturing areas.
  • Independently manage multiple assessments, priorities, and deliverables while meeting project timelines and quality expectations.
  • Experience supporting purification, fermentation, process equipment, utilities, or pharmaceutical manufacturing systems is preferred.
Qualifications
  • Bachelor's Degree in Engineering or related technical discipline.
    • Minimum of 4 years of engineering experience in the pharmaceutical, biotechnology, or other regulated manufacturing industry.
  • Experience performing technical assessments of manufacturing equipment in a regulated environment.
  • Strong understanding of cGMP regulations and quality system requirements.
  • Excellent technical writing, communication, and problem-solving skills.
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.

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