Senior Validation & Process Engineer: Driving Compliance

Efficient Auditing; Seattle (WA); On-site; USD 120,000 - 170,000; Full time

Job summary

Efficient Auditing seeks a Senior Validation & Process Engineer to lead validation lifecycle activities across pharmaceutical, biotech, and medical device manufacturing environments in the Seattle area. You will drive IQ/OQ/PQ, PV, cleaning validation, and CAPA while ensuring adherence to FDA/EMA and global GMP standards.

You will collaborate with engineering, QA, QC, manufacturing, and regulatory teams to keep programs audit-ready and aligned with regulatory expectations, enabling robust,

Qualifications

• Bachelor's or Master's degree in Engineering, Biotechnology, Pharmaceutical Science, or related discipline.
• 4–10 years of validation experience in pharmaceutical, biotech, or medical device industries.
• Strong knowledge of validation lifecycle principles, quality systems, and global GMP requirements.
• Experience with equipment qualification, utilities, process validation, and cleaning validation.
• Familiarity with ICH, FDA 21 CFR Parts 210/211, ISO 13485, GAMP 5, and other relevant regulations.
• Excellent technical writing and documentation skills.
• Strong problem-solving, analytical, and communication abilities.

Responsibilities

• Lead development and execution of validation protocols (IQ, OQ, PQ, PV).
• Conduct process validation activities to ensure quality and performance.
• Align validation programs with FDA/EMA/WHO/PIC/S regulatory expectations.
• Review validation documentation: URSs, protocols, reports, risk assessments.
• Perform TMV, MSA, and DOE as needed.
• Troubleshoot deviations, identify root causes, implement CAPA.
• Evaluate processes and suggest optimization to reduce variability.
• Collaborate with engineering, QA, QC, manufacturing, and regulatory teams.
• Prepare clients for regulatory inspections; ensure audit-ready documentation.
• Participate in equipment onboarding, facility qualification, and tech transfers.

Skills

Validation lifecycle

Equipment qualification

Process validation

Cleaning validation

Regulatory compliance

Technical writing

Root cause analysis

CAPA

DOE

GMP knowledge

Education

Bachelor's degree in Engineering/related

Master's degree in Engineering/related

Tools

eQMS platforms

IQ/OQ/PQ tooling

Job description

Efficient Auditing seeks a Senior Validation & Process Engineer to lead validation lifecycle activities across pharmaceutical, biotech, and medical device manufacturing environments in the Seattle area. You will drive IQ/OQ/PQ, PV, cleaning validation, and CAPA while ensuring adherence to FDA/EMA and global GMP standards.

You will collaborate with engineering, QA, QC, manufacturing, and regulatory teams to keep programs audit-ready and aligned with regulatory expectations, enabling robust,