Senior Validation Engineer - GMP Compliance Lead

Pfizer Inc; McPherson (KS); On-site; USD 83,000 - 138,000; Full time

Benefits offered by this job

401(k) plan with Pfizer Matching Con-

Paid vacation

Holiday and personal days

Health benefits: medical, prescription

Relocation assistance may be available

Job summary

Pfizer is seeking a Validation specialist to lead complex projects, ensure cGMP compliance, and support QA investigations. You will act as a SME for Quality systems, including Change Control and Documentation, and perform protocol authoring and on-floor validation.

Responsibilities include coordinating testing across functions, maintaining the Site Validation Master Plan, and supporting regulatory audits related to sterility equipment and computer systems.

Qualifications

• Bachelor’s degree or higher with relevant experience.
• Strong knowledge of cGMPs, ISPE, and data integrity practices.
• Experience with IQ/OQ/PQ and SOPs; able to work independently.
• Excellent verbal and written communication skills.

Responsibilities

• Lead completion of complex validation projects with team plans.
• Provide high level data analysis support for QA investigations.
• Author/approve validation protocols and reports; on-floor execution.
• Coordinate testing with affected groups and evaluate results.
• Support regulatory audits and deviation investigations as needed.
• Maintain validation master plan and integrate with production schedules.

Skills

Data analysis

Quality systems

cGMPs

ISPE

21 CFR Part 11

Validation

Education

Bachelor's degree

Master's degree

Associate degree

High school diploma

Job description

Pfizer is seeking a Validation specialist to lead complex projects, ensure cGMP compliance, and support QA investigations. You will act as a SME for Quality systems, including Change Control and Documentation, and perform protocol authoring and on-floor validation.

Responsibilities include coordinating testing across functions, maintaining the Site Validation Master Plan, and supporting regulatory audits related to sterility equipment and computer systems.