Senior Validation Engineer – GMP & QC Compliance Lead

Regulatory Jobs; McPherson (KS); On-site; USD 83,000 - 138,000; Full time

Job summary

Pfizer in the United States is seeking a Validation/Quality Assurance professional to lead complex validation activities, ensure cGMP compliance, and support regulatory audits.

The role emphasizes IQ/OQ/PQ, Change Control, Documentation, and Investigations, with on-site requirements and up to 10% travel. Strong independent work ethic and excellent communication are essential for success in this fast-paced environment.

Qualifications

• Bachelor's degree with at least 2 years of experience or higher degrees with related experience.
• Strong understanding of cGMPs, ISPE, Data Integrity, 21 CFR Part 11, IQ/OQ/PQ and SOPs.
• Ability to work independently with limited oversight.
• Strong verbal and written communication skills.

Responsibilities

• Lead the completion of assigned complex projects, meet targets and develop plans for work activities on projects within a team.
• Provide high level data analysis support for Quality Investigations or troubleshooting.
• Coordinate and communicate all testing with affected functional groups and evaluate test results.
• Maintain Site Validation Master Plan and support regulatory audits.
• Lead and support product transfers/new product development and regulatory queries.

Skills

Independent work capability

Verbal and written communication

Analytical thinking

Education

Bachelor's degree with 2+ years experience

Master's degree with more than 0 years experience

Associate's degree with 6 years experience

High school diploma with 8 years experience

Job description

Pfizer in the United States is seeking a Validation/Quality Assurance professional to lead complex validation activities, ensure cGMP compliance, and support regulatory audits.

The role emphasizes IQ/OQ/PQ, Change Control, Documentation, and Investigations, with on-site requirements and up to 10% travel. Strong independent work ethic and excellent communication are essential for success in this fast-paced environment.