About the role

Process Engineer III at Just Evotec Biologic supporting upstream processing projects and leading quality initiatives. Collaborating with multidisciplinary teams in a fast-paced biopharmaceutical environment.

Responsibilities

Promotes a culture of safety
Represents site MSAT on internal and external project teams as technical subject matter expert (SME)
Interfaces with global MSAT, Manufacturing Operations and Quality functions
Authors, reviews and approves GMP process related documentation (technical documents, test protocols, batch records, process descriptions, SOPs)
Leads complicated and multi-disciplinary change controls and will function as a lead for the project team
Partner with Manufacturing to develop high-quality batch records, robust processes and innovative technology solutions
Utilize technical skills and process knowledge to participate and/or lead investigations related to process issues/deviation
Collaborate with impacted groups to drive implementation of CAPAs from approval to closure & effectiveness check
Lead quality and technical risk assessment activities
Support and/or lead technology transfer or new production introduction activities
Provide training and technical knowledge sharing to manufacturing
Partner with Validation and Quality groups in supporting equipment onboarding activities and periodic review programs as process owners
Support and on-call rotating to support 24/7 operations
Confident to act as a subject matter expert for regulatory and client inspection audits
Apply Operational Excellence principles to lead continuous improvement ideas for manufacturing and technology transfer related activities

Masters (or Bachelors) degree in Engineering with 4+ (7+) years of pharmaceutical/biotech experience
Minimum of 2+ years of supporting upstream cell culture activities for biopharmaceutical products
Knowledge and experience CMC stage gates for clinical and commercial biologics drug substance manufacturing programs
Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology
Solid understanding of upstream processing including hands on experience in single-use bioreactor operations and perfusion technology
Solid understanding of GMP concepts and quality systems necessary to support manufacturing and new production introduction activities
Working knowledge of manufacturing process equipment and automation systems
Experienced deviation investigator and knowledgeable of root cause analysis tools (RCA)
Possess strong focus on quality and attention to detail as well as effective task/ time management organizational skills
Ability to organize, analyze/interpret, and effectively communicate process data
Demonstrated capabilities to work with high-performing teams, drive change, and influence internal and external stakeholders
Extensive knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing.