Sr. Process Engineer

BioSpace has been engaged with our client, San Diego biopharmaceutical company who develops vaccines and antibody therapeutics for infectious diseases, opioid overdoses, and provides medical devices for biodefense purposes.

The Senior Process Engineer will be a member of the Process Development and Production team. This position will be focused on the support of clinical production in a cGMP facility, as well as, leading/supporting projects focused on equipment design, specification, installation, commissioning, qualification, and process scale-up. This includes but is not limited to creating process budgets and managing external resources.

Essential Functions

• Lead the design, implementation and sustainability of manufacturing processes from feasibility through scale-up and commercial manufacturing
• Ensure robust systems using accepted GMP design controls
• Working with cross-functional teams to determine system requirements and specifications
• Create, contribute to, and review process deviation risk assessments and CAPA reports
• Evaluate incoming processes for operability and develop risk assessment plans
• Process development, scale-up, technology transfer and equipment/process validation activities
• Author, review, and approve all SOPs and technical documents throughout the equipment/system lifecycle from commissioning and qualification through decommissioning and retirement
• Responsible for coordination of technical activities on assigned projects
• Maintain compliance with applicable cGMP regulations, vendor guidelines, engineering principles, and documentation

Minimum Education, Experience and Skills

• Bachelor’s Degree in an engineering discipline or equivalent with 8 years of process experience in the biotech or pharmaceutical industry; PE license preferred
• Expert knowledge in upstream and downstream bioprocessing
• Excellent written and interpersonal skills
• Strong data analysis, troubleshooting and problem-solving skills
• Strong understanding of equipment qualification, validation, scale up and tech transfer
• Manage relevant engineering activities and prioritize work to ensure site and project timelines are met
• Expert knowledge in practice of researching, engineering, and design, as well as evaluating alternatives
• Expert knowledge of engineering principles, standards, techniques, policies, and processes.
• Experience with Facility Design/Expansion
• Knowledge of cGMPs and experience working in a GMP biotechnology or pharmaceutical manufacturing setting
• Detailed knowledge of facilities, systems, and infrastructure within a regulated industry setting
• Ability to read and understand drawings, schematics, tolerances, and limits

Preferred:

• Fill/finish knowledge
• Experience in Design of Experiments (DOE) and use of statistical analysis software (JMP)
• Working knowledge of design (Solidworks) and fabrication of parts and assemblies
• Understanding of 21 CFR parts 11, 210 and 211 a plus
• Working within a controlled production environment
• Working with potentially infectious materials