Senior Engineer, Quality Engineering

Responsibilities:

• Serve as the Quality Assurance subject matter expert on qualification, cleaning validation, process validation, and continued process verification (CPV), including guidance, review, and approval of system requirements, process design, risk assessments, and validation documentation (including cleaning/process validation documentation, templates, risk assessments, and parameter classification).
• Draft, review, and approve qualification/validation procedures and support GMP quality systems.
• Mentor Quality Assurance members on Quality Engineering functions (e.g., audits, cleaning validation, equipment qualification, process validation, validation assessments, CPV).
• Collaborate with cross-functional teams to review and approve internal and vendor-generated validation/qualification/commissioning data and documentation.
• Support issuance, review, tracking, and approval of internal deviations, change controls, and CAPAs related to validation.
• Support periodic reviews of validated systems/processes, including CPV procedures for commercial manufacturing.
• Perform secondary review of registration batches for systemic issues.
• Prepare documentation and support internal and external audits.

• Bachelor’s degree (or higher) in a science field.
• Bachelor’s degree with 15+ years of experience in cGMP-regulated manufacturing, specifically in validation-related roles in manufacturing and/or quality.
• Working knowledge of GMP regulations (21
  
  CFR Part 210/211, EU Annex 11/15, ICH Q7, 21
  
  CFR Part 11).
• Excellent attention to detail and organizational skills; ability to multitask/prioritize with minimal supervision.
• Excellent interpersonal, verbal, and written communication skills.
• Proficient with Microsoft Word and Excel.

• Prior experience with electronic document management systems in regulated environments.

Benefits/Pay (as stated):
Wisconsin pay range $125,000 USD - $140,000 USD.