Senior Process Engineer – Aseptic Fill-Finish & Transfer

Zohorecruit; South Carolina; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical, Dental, Vision benefits

401(k) and matching

Paid time off & holidays

Education assistance

Pet Insurance

Wellness/fitness discounts

Job summary

BioTechnique is seeking a Senior Process Engineer to lead aseptic manufacturing, technology transfer, and process validation across development to commercial operations. You will collaborate with Manufacturing, Quality, Validation, Facilities, and Supply Chain to translate client needs into robust processes.

The role requires a strong background in sterile fill-finish, cGMP, and regulatory expectations, with emphasis on process characterization and continuous improvement in a fast-paced CDMO

Qualifications

• Bachelor's degree in engineering.
• 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 and fill-finish.
• Experience with GMP documentation, process validation, and tech transfer.

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, compounding, 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.
• Author and execute PVMPs, PPQ Protocols/Reports, CPV programs.
• Support aseptic processing programs in compliance with FDA cGMP, Annex 1, ICH, and USP.

Skills

Aseptic manufacturing

Fill-finish operations

GMP documentation

Process investigations

Technology transfer

Process validation

Education

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

Job description

BioTechnique is seeking a Senior Process Engineer to lead aseptic manufacturing, technology transfer, and process validation across development to commercial operations. You will collaborate with Manufacturing, Quality, Validation, Facilities, and Supply Chain to translate client needs into robust processes.

The role requires a strong background in sterile fill-finish, cGMP, and regulatory expectations, with emphasis on process characterization and continuous improvement in a fast-paced CDMO