Senior Validation Engineer - cGMP Process Expert

ADP, Inc.; Plymouth (MN); On-site; USD 94,000 - 130,000; Full time

Benefits offered by this job

401k with company match

Profit sharing program

Medical insurance

HSA / FSA

Vision insurance

Life insurance

Paid family medical leave

Long-term disability insurance

Hospital indemnity

Critical illness

Accident coverage

Identity theft protection

Pet insurance

Job summary

ProMed, Minnesota-based CDMO, is seeking a Senior Engineer, Validation to own qualification and validation activities across multiple client programs. You will develop VMPs, PQ/PPQ, and cleaning validation, ensuring cGMP compliance and regulatory readiness.

The role emphasizes risk-based strategies, written SOPs, QA collaboration, and mentorship of junior engineers, with strong technical writing and cross-functional communication as key success factors.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Pharmaceutical Sciences, or related field.
• 5+ years of experience in validation, equipment qualification, or process engineering within pharmaceutical/biotech/CDMO environments.
• Experience authoring and executing manufacturing process and/or cleaning validation studies.
• Working knowledge of statistical tools used in validation and CPV.
• Experience supporting regulatory inspections or client audits related to validation activities.
• Strong written and verbal communication skills.

Responsibilities

• Author and maintain Validation Master Plans (VMPs) for equipment, utilities, and process validation.
• Develop risk-based validation strategies that align with regulatory expectations (FDA, EMA, ICH Q7/Q8/Q9/Q10) and client requirements.
• Establish and maintain validation policies, SOPs, and templates to support consistent execution across programs.
• Partner with Quality Assurance to ensure validation approaches are appropriately risk-assessed and documented.
• Author and execute PQ and PPQ protocols for manufacturing processes transferring from development to commercial-scale production.
• Develop and execute cleaning validation protocols, including selection of worst-case products, swab/rinse sampling plans, and acceptance criteria based on toxicological limits.

Skills

Process validation

Technical writing

CGMP knowledge

Statistical analysis

Project management

Cross-functional communication

Education

Bachelor's degree

Job description

ProMed, Minnesota-based CDMO, is seeking a Senior Engineer, Validation to own qualification and validation activities across multiple client programs. You will develop VMPs, PQ/PPQ, and cleaning validation, ensuring cGMP compliance and regulatory readiness.

The role emphasizes risk-based strategies, written SOPs, QA collaboration, and mentorship of junior engineers, with strong technical writing and cross-functional communication as key success factors.