Aseptic Process Engineer - Tech Transfer & Validation

PSC Biotech; York, Northern (York County, KY); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical premiums

401(k) Matching

PTO & Holidays

Education Assistance

Pet Insurance

Fitness Benefits

Job summary

BioTechnique seeks a Process Engineer (Mid-Level to Senior) to support aseptic manufacturing, technology transfer, and process validation in our sterile injectable CDMO operations. This role leads technical transfer from clients into BioTechnique, ensuring scalable, compliant manufacturing from development to commercialization.

Ideal candidates have 4–8 years in pharmaceutical manufacturing, strong GMP knowledge, and hands-on aseptic experience.

Qualifications

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, Biotechnology, or related field.
• 4-8 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 and fill-finish.
• Familiarity with GMP documentation and technology transfer.

Responsibilities

• Lead process transfer activities from clients into BioTechnique manufacturing operations.
• Review client process documentation, batch records, process descriptions, and development reports.
• Develop strategies for aseptic fill-finish, sterile filtration, lyophilization, and packaging.
• Author and review technology transfer protocols, reports, and risk assessments.
• Support engineering runs, water runs, media fills, and demonstration batches.
• Provide floor support during aseptic manufacturing campaigns and troubleshoot deviations.
• Drive process improvements to increase throughput and quality.
• Lead qualification activities (IQ/OQ/PQ) and regulatory documentation when required.

Skills

Aseptic processing

Process validation

Technology transfer

cGMP knowledge

Quality systems

Data analytics

Team leadership

Education

Bachelor's degree in Chemical/Pharmaceutical/related engineering

Job description

BioTechnique seeks a Process Engineer (Mid-Level to Senior) to support aseptic manufacturing, technology transfer, and process validation in our sterile injectable CDMO operations. This role leads technical transfer from clients into BioTechnique, ensuring scalable, compliant manufacturing from development to commercialization.

Ideal candidates have 4–8 years in pharmaceutical manufacturing, strong GMP knowledge, and hands-on aseptic experience.