This individual and position will support the Internal Manufacturing and Engineering (IME) Drug Substance Organization (DSO) Technical Operations group at Bioscience Laboratories Irvine (BLI) and Bioscience Laboratories Campbell (BSL) based in Irvine California. The DSO Technical Operations organization provides Engineering and Operational Excellence supporting, Commercial and Clinical Products & Processes, API’s, Process Development, Improvements, Tech and Site Transfers and New Technologies. In addition, this position will support the implementation of strategic capital projects involving, process equipment design, installations, testing, commissioning and support to Engineering, Validation and Manufacturing. The DSO Technical Operations currently has 6 positions located in Irvine, CA & Campbell, CA supports three independent Biologics Manufacturing Suites.
- Support existing commercial Biologics API processes, products in the pipeline, including optimizations and technology transfers; supporting; Commercial and Clinical Phase Manufacturing, Process Development and Regulatory. Also, providing cross-organizational support to; Engineering, Manufacturing, Validation & Quality.
Support DSO IME Process Engineering initiatives; planning and execution of strategic process equipment capital projects, Process Improvements, Deviation Investigations, Risk Assessments & Change Management.
Lead / Support / Implement process equipment projects’ life cycle; Design, Procurement, c-GMP documentation (URS, Design Specifications, FAT, SAT & Commissioning), Testing, Installations, Startups & Commissioning of cGMP Manufacturing systems delivering robust & compliant solutions, improving processes & equipment trains within regulated guidelines, while meeting business needs, timelines & budget.
- Bachelor of Science in Chemical Engineering, or similar Scientific/Engineering background is required.
- 5 - 7 years of experience in; Process Engineering, Project Engineering & Manufacturing roles in c-GMP, regulated Biologics industry.
- Project Engineering & Project Management skills to successfully implement process equipment projects from design to Commissioning & Validation.
- Working knowledge of c-GMP regulations and agency guidelines.
- Demonstrated knowledge of c-GMP Manufacturing Operations, Regulatory requirements (FDA); Pharmaceutical / Biologics process equipment design & operation; Biologics upstream & downstream processes; Fermentation, Ultrafiltration / Diafiltration, Purification, Ion-Exchange Chromatography, Chemical & Heat Sterilizations and Clean-In-Place.
- Excellent communication and customer-oriented skills with ability to work in a matrix / cross-functional organization.
- Results-driven, hands-on approach with high sense of responsibility, ownership & accountability.
- Flexible in work requirements and willingness to accept & embrace change.
- Ability to travel approx. 25% of the time to other AbbVie sites as well as travel for Project Activities (e.g., FAT execution) of process equipment at vendors’ sites.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced