Process Engineer

BioTechnique Overview

BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team’s expertise to create a process design for our clients’ products that best suits their needs.

Your Role

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.

• Support 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: Process Validation Master Plans (PVMP), PPQ Protocols and Reports, Continued Process Verification (CPV) Programs, Process Risk Assessments, Media Fill Protocols.
• Analyze process data and recommend improvements based on statistical and scientific principles.
• Support successful execution of PPQ campaigns.
• Aseptic Processing Support:
  • Support aseptic processing programs in compliance with: FDA cGMP regulations, EU GMP Annex 1, ICH Guidelines, USP requirements.
  • Participate in aseptic process simulations (APS/media fills).
  • Evaluate smoke studies, environmental monitoring trends, contamination control strategies, and operator qualification programs.
  • Support contamination control and sterility assurance initiatives.
  • Equipment & Facility Engineering Support:
    • Qualification and implementation of: Filling lines, Isolators, RABS systems, Lyophilizers, CIP/SIP systems, Sterile filtration systems, Compounding equipment, Visual inspection systems.
    • Collaborate with Validation and Facilities teams during IQ/OQ/PQ activities.
    • Assess equipment performance and recommend improvements.
    • Lyophilization Support:
      • Support cycle development, scale-up, and process optimization activities.
      • Review thermal characterization and freeze-drying data.
      • Support lyo process validation and technology transfer projects.
      • Investigate cycle anomalies and process variability.
      • Continuous Improvement:
        • Lead Lean Manufacturing and Operational Excellence initiatives.
        • Utilize data analytics and process monitoring tools to improve performance.
        • Support OEE improvement programs.
        • Implement process robustness and reliability improvements.
        • Regulatory & Audit Support:
          • Support internal and external audits.
          • Participate in client audits and regulatory inspections.
          • Provide SME support during FDA and customer inspections.
          • Prepare technical documentation for regulatory submissions when required.

  Requirements

  • Bachelor's degree in: Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, Biotechnology, Related Engineering Discipline.
  • 4-8 years of pharmaceutical manufacturing experience.
  • Minimum 3 years supporting aseptic manufacturing operations.
  • Demonstrated experience with: Sterile injectable manufacturing, Fill-finish operations, GMP documentation, Process investigations, Technology transfer, Process validation.
  • PREFERRED EXPERIENCE:
    • In a CDMO environment.
    • Experience supporting biologics, vaccines, mAbs, gene therapy products, peptides, or sterile small molecules.
    • Experience with lyophilization cycle development and optimization.
    • Familiarity with Annex 1 contamination control requirements.
    • Project management experience.
    • Six Sigma Green Belt or Black Belt certification.

  Benefits

  We offer a full suite of benefits, including medical, dental, and vision coverage, insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability, and more. We also offer a 401(k) and 401(k) matching plan, PTO, Sick Time, and Paid Holidays. Additionally, we provide education assistance, pet insurance, fitness benefits, financial perks and discounts, and equal opportunity employment.