Sterile Filling Validation Engineer
Job in
Winston-Salem, Forsyth County, North Carolina, 27104, USA
Listed on 2026-07-28
Listing for:
United Pharma
Full Time
position Listed on 2026-07-28
Job specializations:
-
Engineering
Validation Engineer, Pharma Engineer, Quality Engineering
Job Description & How to Apply Below
We are seeking an experienced Sterile Filling Validation Engineer to support qualification and validation activities for new vial and syringe filling operations. The role will focus on aseptic processing, filling line qualification, process validation, media fills, and operational readiness within a GMP-regulated manufacturing environment.
Key Responsibilities- :
• Support startup, commissioning, and qualification of sterile filling line - s
• Execute process validation and PQ activities for vial and syringe filling operation - s
• Support media fills and aseptic process simulation - s
• Investigate process deviations and assist with corrective action - s
• Prepare validation reports, protocols, and technical documentatio - n
• Support operational readiness and successful transition to manufacturin - g
• Collaborate with Manufacturing, Quality, Engineering, and Validation team
- s:
• 5+ years of sterile pharmaceutical manufacturing experien - ce
• Strong experience supporting aseptic processing operatio - ns
• Hands-on process validation and qualification experien - ce
• Strong understanding of GMP and sterile manufacturing require men - ts
• Isolator qualification experience is a pl - us
• Vial filling, syringe filling, and commercial startup experience preferr - ed
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