Job description
Join Adecco as a Senior Process Engineer in Biopharma / Life Science. This role is based in the Central Region and offers the opportunity to translate innovative science into robust, scalable manufacturing processes. You will collaborate with cross-functional teams across R&D, Manufacturing, QA/QC, and external equipment vendors to accelerate tech transfer and optimize production performance while maintaining strict GMP and regulatory standards.
You will own process development activities from concept to validation, lead scale-up efforts from lab or pilot to GMP production, and drive continuous improvement using data-driven methods, DOE, PAT, and QbD principles. Your work will focus on both upstream (cell culture/fermentation) and downstream (purification) operations, with the goal of delivering repeatable, high-quality outputs that meet safety and efficacy requirements.
As a senior engineer, you will mentor junior teammates, draft and review critical documentation (SOPs, change controls, tech transfer packages), and partner with Manufacturing, QA/QC, Engineering, and Vendors to qualify new equipment and single-use systems. You will participate in risk assessments, CAPA investigations, and process characterization to ensure robust performance and regulatory readiness. Adequate communication and leadership will be essential as you present findings to stakeholders and influence site-level process engineering capabilities.
Adecco offers a competitive package with AWS, VB, and comprehensive employee benefits. We value curiosity, collaboration, and accountability, and provide opportunities for professional growth within a dynamic biopharma environment.
Responsibility
- Lead end-to-end process development and optimization for biopharmaceutical manufacturing, covering upstream (cell culture/fermentation) and downstream (purification) operations.
- Drive scale-up from lab/pilot to GMP production, ensuring process robustness, reproducibility, and regulatory compliance.
- Design and execute DOE studies, implement PAT and QbD strategies to improve yield, purity, throughput, and cost of goods.
- Collaborate with Manufacturing, QA/QC, Engineering, and Vendors to qualify equipment and implement single-use systems and technology transfers.
- Investigate deviations, perform root cause analysis, implement CAPAs, and lead continuous improvement initiatives with cross-functional teams.
- Author and review technical documentation including process descriptions, SOPs, change controls, and tech transfer packages; support regulatory submissions as needed.
- Ensure GMP, HSE, and regulatory compliance; perform risk assessments and maintain robust documentation and traceability.
- Mentor and coach junior engineers; lead project teams and communicate findings to stakeholders.
Qualification
- Bachelor's degree in Chemical Engineering, Bioengineering, Bioprocess Engineering or related field; Master's preferred.
- 5+ years of hands-on biopharma process development, scale-up, and tech transfer in a GMP environment.
- Strong knowledge of upstream/downstream processing including cell culture, fermentation, purification, chromatography, filtration, and sterile fill.
- Proficiency in DOE, statistics (Minitab, JMP, Excel), data analysis, and process optimization.
- Familiarity with PAT, QbD, regulatory guidelines (FDA/EMA), and quality systems (CAPA, deviation management, change control).
- Experience with equipment qualification (IQ/OQ/PQ) and commissioning; knowledge of single-use systems and bioprocess equipment.
- Excellent communication, collaboration, and technical-writing skills; ability to lead cross-functional teams and influence decisions.
- Willingness to travel as needed.