Manufacturing Engineer IIIUnited States - California - OceansideManufacturing Operations & Supply ChainRegular
Kite, a Gilead Company, is a biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies.
The Manufacturing Engineer III will be part of a team that supports the Manufacturing Execution System (MES) and Process Control System (PCS) for Kite’s Viral Vector Manufacturing Facility in Oceanside, CA., primarily responsible for Computer System Validation (CSV) as well as general Automation Engineering responsibilities. The successful candidate will have demonstrated proficiency in CSV concepts including Good Automated Manufacturing Practice (GAMP), Data Integrity, Change Control and Commissioning, Qualification and Validation (CSV) Procedures. In addition to CSV, the successful candidate will have demonstrated proficiency in design, configuration and deployment of configuration changes to MES and PCS systems.
Specific Job Responsibilities (CSV)
- Responsible for performing CSV of automation systems by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
- Executes test plans according to approved procedures, collects samples, tabulates test results, and organizes data packages.
- Compiles and analyzes CSV data, prepares reports and makes recommendations for changes and/or improvements.
- Develop business processes, guidelines, Work Instructions and SOPs to support the CSV of the Automation Systems.
- Coordinates and executes CSV change control responsibilities.
- Maintains all documentation pertaining to CSV.
- Will assist in developing procedures and/or protocols including review work of other team members.
- Coordinates contract personnel through completion of assignments
- Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups as required.
- May provide day-to-day guidance and training to other CSV team members.
- Serves as an information resource to CSV technicians, contractors and vendors.
- Resolves CSV issues of moderate scope with limited direct supervision.
Specific Job Responsibilities (Automation Engineering)
- Translate process requirements and system best practices into practical, usable designs.
- Develop design requirements, functional specifications and system configurations through collaboration with cross-functional team and peers.
- Maintain Automation System configurations per procedure in centralized repository.
- Drive change as a Quality Management System Change Control owner.
- Collaborate with vendors (as part of a team) to define user requirements and ensure the Automation System designs meets business requirements.
- Trouble shooting daily operational system issues to define root cause, working in collaboration with Manufacturing, Quality and Global to build temporary/permanent solutions.
- Travel as required to participate in technical meetings (Approximately 10%).
- Available for 24/7 support (scheduled and off hours).
- Master’s degree in Engineering or Computer Science with 3+ years of experience in Automation Engineering and CSV in the Pharmaceutical, Biotech or Cell Therapy Industry Or
- Bachelor’s degree in Engineering or Computer Science with 5+ years of experience in Automation Engineering and CSV in the Pharmaceutical, Biotech or Cell Therapy Industry Or
- High School diploma with 9+ years of experience in Automation Engineering and CSV in the Pharmaceutical, Biotech or Cell Therapy Industry.
- Working knowledge, understanding and application of CSV principles, concepts, practices, and standards.
- Working knowledge and 3+ years of experience with current Good Manufacturing Practices (cGMPs) and Biopharmaceutical manufacturing regulations.
- Working knowledge and 3+ years of experience with one or more of the following industry recognized systems: Emerson DeltaV PCS, Werum PAS-X MES, Allen Bradley Programmable Logic Controllers (PLC) and OSIsoft PI Data Historian.
- Knowledge of cell culture or cell therapy manufacturing, new product introduction and/or tech transfer.
- Working knowledge of product lifecycle – Product and process development, clinical trials, validation and regulatory submissions, commercial GMP manufacturing.
- Working knowledge and application of ANSI/ISA-88 (process control) and ANSI/ISA-95 (automated interfaces) standards
- Working knowledge and application of Good Automated Manufacturing Practice (GAMP) framework for risk-based approach to CSV.
- Working knowledge and application of IT infrastructure and applications (server virtualization, security, wireless communication protocols, firewalls, etc.
- Strong verbal, written, and interpersonal communication skills.
- Proficient in Microsoft Office applications.
- Lean Six Sigma Green Belt or higher
- Project Management Professional (PMP)