Senior Process Engineer – Aseptic Fill-Finish Leader

PSC Biotech® Corporation; York (York County); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical, Dental, Vision – company paid

401(k) and matching

Paid time off & holidays

Education assistance

Wellness and fitness perks

Job summary

BioTechnique seeks aSenior Process Engineer to lead aseptic manufacturing programs from development through commercial production. You will collaborate across Manufacturing, Quality, Validation, Facilities, Metrology, Supply Chain, and Client Project Teams to translate client processes into robust operations.

The role requires 7+ years in pharmaceutical manufacturing with hands-on aseptic experience and cGMP knowledge, ensuring compliance and continuous improvement.

Qualifications

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, Biotechnology, or related engineering discipline.
• 7+ years of pharmaceutical manufacturing experience.
• Minimum 3 years supporting aseptic manufacturing operations.
• Must be authorized to work in the U.S.
• No C2C at this time.
• Experience with sterile injectable manufacturing, fill-finish, GMP documentation, process investigations, technology transfer, and process validation.

Responsibilities

• Lead process transfer activities from clients into BioTechnique manufacturing operations.
• Review client process documentation, batch records, process descriptions, and development reports.
• Develop manufacturing process strategies for aseptic fill-finish, sterile filtration, and lyophilization.
• Author and review technology transfer protocols, reports, risk assessments, and process characterization documents.
• Support engineering runs, water runs, media fills, and demonstration batches.
• Provide floor support during aseptic manufacturing campaigns.
• Troubleshoot process deviations, equipment issues, yield losses, and process excursions.
• Support investigations, CAPAs, and root cause analyses.
• Drive process improvements that increase throughput, quality, and operational efficiency.
• Provide technical leadership during critical manufacturing operations.
• Author and execute PVMPs, PPQ protocols and reports, CPV programs, and process risk assessments.

Skills

Sterile injectable manufacturing

Fill-finish operations

GMP documentation

Process investigations

Technology transfer

Process validation

Project management

Education

Bachelor's degree in Chemical/Biochemical/Mechanical/Pharmaceutical Engineering or Biotechnology

Job description

BioTechnique seeks aSenior Process Engineer to lead aseptic manufacturing programs from development through commercial production. You will collaborate across Manufacturing, Quality, Validation, Facilities, Metrology, Supply Chain, and Client Project Teams to translate client processes into robust operations.

The role requires 7+ years in pharmaceutical manufacturing with hands-on aseptic experience and cGMP knowledge, ensuring compliance and continuous improvement.