Senior Validation Engineer — Aseptic Process & Equipment Expert

Biopharma Careers; City of Rochester (NY); On-site; USD 83,000 - 138,000; Full time

Benefits offered by this job

Relocation assistance

Health benefits

Paid time off and leave

Job summary

Pfizer is seeking a Validation/Qualification professional to support manufacturing equipment, facilities, and critical utilities in a penicillin manufacturing environment. This role emphasizes developing and executing validation documentation, risk assessments, and master plans for process equipment and facilities.

You will lead cross-functional validation projects, support regulatory audits, and mentor teammates to ensure ongoing compliance and continuous process improvement.

Qualifications

• Bachelor's degree with 2+ years of experience OR Master's with 0+ years OR Associate's with 6+ years OR high school and 8+ years experience.
• Experience with sterile products and medical devices is a plus.
• Strong analytical/problem-solving skills and regulatory awareness.

Responsibilities

• Validate equipment, facilities, and utilities across validation lifecycle.
• Author and execute validation/qualification documents (IQ/OQ/PQ, URS, FAT/SAT, DQ, etc.).
• Lead/coordinate cross-functional validation projects to reduce process risk.
• Support audits and continuous improvement initiatives.
• mentor and train colleagues on process validation practices.
• Review changes to ensure validated state remains intact.

Skills

Validation/Qualification

Aseptic gowning

Regulatory audits

Problem solving

Cross-functional collaboration

Mentoring

Education

Bachelor's degree

Master's degree

Associate's degree

High school diploma

Tools

GxP validation tools

Computer systems validation

Job description

Pfizer is seeking a Validation/Qualification professional to support manufacturing equipment, facilities, and critical utilities in a penicillin manufacturing environment. This role emphasizes developing and executing validation documentation, risk assessments, and master plans for process equipment and facilities.

You will lead cross-functional validation projects, support regulatory audits, and mentor teammates to ensure ongoing compliance and continuous process improvement.