Senior Aseptic Process Engineer – Tech Transfer

PSC Biotech; York (York County); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical & Dental

Vision coverage

401(k) with match

Paid time off

Education assistance

Pet insurance

Fitness benefits

Job summary

PSC Biotech is seeking a highly motivated Senior Process Engineer to support aseptic manufacturing, technology transfer, process validation, and continuous improvement activities within our sterile injectable CDMO operations. This role serves as a technical leader responsible for translating client manufacturing processes into robust, scalable, and compliant commercial operations.

The Senior Process Engineer will collaborate across Manufacturing, Quality, Validation, Facilities, Metrology,

Qualifications

• Bachelor's degree in Chemical/ Biochemical/ Mechanical/ Pharmaceutical Engineering or related field.
• 7+ years of pharmaceutical manufacturing experience.
• Minimum 3 years supporting aseptic manufacturing operations.
• Must be authorized to work in the U.S.
• Experience with sterile injectable manufacturing, fill-finish, GMP documentation, investigations, technology transfer, and 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, lyophilization, and packaging operations.
• 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.

Skills

Aseptic manufacturing

Fill-finish

GMP documentation

Process investigations

Technology transfer

Process validation

US work authorization

Education

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

Job description

PSC Biotech is seeking a highly motivated Senior Process Engineer to support aseptic manufacturing, technology transfer, process validation, and continuous improvement activities within our sterile injectable CDMO operations. This role serves as a technical leader responsible for translating client manufacturing processes into robust, scalable, and compliant commercial operations.

The Senior Process Engineer will collaborate across Manufacturing, Quality, Validation, Facilities, Metrology,