Senior Process Engineer – Aseptic Fill-Finish & Transfer

PSC Biotech® Corporation; York (York County); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical, Dental, and Vision premiums

401(k) and matching

PTO, Sick Time, paid Holidays

Education Assistance

Pet Insurance

Fitness Benefits

Job summary

BioTechnique is seeking a highly motivated Senior Process Engineer to support aseptic manufacturing, technology transfer, process validation, and continuous improvement. This role leads translating client processes into scalable, compliant operations across manufacturing, quality, validation, facilities, and supply chain.

The successful candidate will have strong aseptic processing knowledge, cGMP experience, and expertise in process validation and design transfer.

Qualifications

• Bachelor’s degree in a relevant engineering field and 7+ years of pharmaceutical manufacturing experience.
• Minimum 3 years supporting aseptic manufacturing operations.
• Authorized to work in the U.S. and no C2C arrangements.
• Demonstrated experience with sterile injectable manufacturing, fill‑finish, GMP docs, and process validation.

Responsibilities

• Lead process transfer activities from clients into BioTechnique operations.
• Develop manufacturing strategies for aseptic fill‑finish, lyophilization, and packaging.
• Author/review PVMPs, PPQ protocols, CPV programs, and risk assessments.
• Provide technical leadership during critical manufacturing operations.
• Support regulatory submissions and client audits.

Skills

Sterile injectable manufacturing

Fill-finish operations

Process validation

Aseptic processing

Continuous improvement

Education

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

Tools

GMP documentation

Technology transfer

PPQ / PV protocols

Job description

BioTechnique is seeking a highly motivated Senior Process Engineer to support aseptic manufacturing, technology transfer, process validation, and continuous improvement. This role leads translating client processes into scalable, compliant operations across manufacturing, quality, validation, facilities, and supply chain.

The successful candidate will have strong aseptic processing knowledge, cGMP experience, and expertise in process validation and design transfer.