Senior Validation Engineer: Lead PQ/PPQ Across Programs

ProMed Molded Products; Minneapolis (MN); Sur place; USD 110 000 - 160 000; Plein temps

Résumé du poste

ProMed Molded Products is seeking a Senior Validation Engineer to lead validation activities for equipment, utilities, and processes in a regulated manufacturing environment.

You will author and execute PQ/PPQ protocols, develop risk-based validation strategies aligned with FDA/EMA ICH guidelines, and collaborate with QA, Process Development, and Manufacturing teams while mentoring junior engineers.

Qualifications

• Bachelor's degree in Engineering, Chemistry, or related field.
• 5+ years in validation/equipment qualification in pharma/CDMO.
• Experience with regulatory inspections or client audits.
• Ability to author/execute validation protocols and reports.

Responsabilités

• Author and maintain Validation Master Plans (VMPs).
• Develop risk-based validation strategies aligned with regulatory expectations (FDA, EMA, ICH).
• Author and execute PQ and PPQ protocols for manufacturing processes.
• Collaborate with Quality Assurance, Process Development, and Manufacturing.
• Mentor junior validation engineers and provide guidance on protocols.

Connaissances

Statistical analysis

Technical writing

Cross-functional communication

Validation leadership

Formation

Bachelor's degree in Engineering/Chemistry/Pharmaceutical Sciences

Description du poste

ProMed Molded Products is seeking a Senior Validation Engineer to lead validation activities for equipment, utilities, and processes in a regulated manufacturing environment.

You will author and execute PQ/PPQ protocols, develop risk-based validation strategies aligned with FDA/EMA ICH guidelines, and collaborate with QA, Process Development, and Manufacturing teams while mentoring junior engineers.