Aseptic Process Engineer: Tech Transfer & Validation

PSC Biotech; South Carolina; On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) and matching

PTO, Sick Time, Holidays

Education Assistance

Pet Insurance

Job summary

BioTechnique is seeking a highly motivated Process Engineer (Mid-Level to Senior-Level) 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 Process Engineer will collaborate across Manufacturing, Quality, Validation, Facilities,

Qualifications

• Bachelor's degree in Chemical/biochemical/mechanical/pharmaceutical engineering or related field.
• 4–8 years of pharmaceutical manufacturing experience.
• Minimum 3 years supporting aseptic manufacturing operations.
• Authorized to work in the U.S.
• Experience with sterile injectable manufacturing, fill-finish, GMP documentation, process validation, and tech transfer.
• Familiarity with lyophilization is a plus.

Responsibilities

• Lead process transfer activities from clients into BioTechnique manufacturing operations.
• Review client process docs, batch records, and development reports.
• Develop manufacturing strategies for aseptic fill-finish, lyophilization, and packaging.
• Author and review technology transfer protocols and risk assessments.
• Support engineering runs, water runs, media fills, and demonstration batches.
• Provide floor support during aseptic manufacturing campaigns.
• Troubleshoot deviations and equipment issues.
• Drive process improvements to increase throughput and quality.
• Support regulatory submissions with technical documentation.
• Collaborate with QA, Validation, Facilities, and Supply Chain teams.

Skills

Sterile injectable manufacturing

Fill-finish operations

Process validation

Technology transfer

GMP documentation

Process investigations

Aseptic processing awareness

Education

Bachelor's degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, Biotechnology, Related Engineering Discipline

Tools

Lyophilization equipment familiarity

QA/QC collaboration tools

Job description

BioTechnique is seeking a highly motivated Process Engineer (Mid-Level to Senior-Level) 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 Process Engineer will collaborate across Manufacturing, Quality, Validation, Facilities,