Process Engineer

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

We are seeking a highly skilled Senior Validation & Process Engineer to support validation, qualification, and process improvement initiatives across pharmaceutical, biotech, and medical device manufacturing environments.
In this role, you will lead validation lifecycle activities, ensure regulatory compliance with FDA, EMA, and global GMP standards, and support clients in maintaining robust and reliable manufacturing processes.
The ideal candidate brings strong technical expertise in equipment qualification, process validation, cleaning validation, and continuous improvement methodologies.

Key Responsibilities

• Lead the development and execution of validation protocols, including IQ, OQ, PQ, and PV.
• Conduct process validation activities to ensure manufacturing processes consistently meet quality and performance requirements.
• Support clients in aligning validation programs with FDA, EMA, WHO, and PIC/S regulatory expectations.
• Review and approve validation documentation such as URSs, protocols, reports, and risk assessments.
• Perform Test Method Validation (TMV), Measurement System Analysis (MSA), and Design of Experiments (DOE) as needed.
• Troubleshoot process deviations, identify root causes, and recommend corrective and preventive actions (CAPA).
• Evaluate manufacturing processes and suggest optimization strategies to improve efficiency, reduce variability, and enhance product quality.
• Work with engineering, QA, QC, manufacturing, and regulatory teams to support compliance and technical investigations.
• Prepare clients for regulatory inspections by ensuring validation programs are audit-ready and fully documented.
• Participate in equipment onboarding, facility qualification, and technology transfer projects.

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.

Preferred Skills

• Certification in validation, quality, or process engineering (CQE, CVQ, etc.).
• Experience in sterile manufacturing, biologics, or highly regulated environments.
• Knowledge of Lean or Six Sigma methodologies.
• Familiarity with digital validation systems and eQMS platforms.

Why Join Us?

• Work on impactful validation projects that support global compliance and product safety.
• Collaborate with leading pharmaceutical and life-science organizations.
• Opportunities to advance into senior consulting, project leadership, or quality management roles.
• Supportive work culture focused on growth, learning, and professional development.
• Be part of a team that values technical excellence, innovation, and regulatory integrity.