PDS Tech, Inc. is seeking a PAT Maintenance Engineer, in Berkeley, CA.
Plant Engineering department supports production with engineering related activities associated with equipment, utilities, instrumentation and PAT (Process Analytical Technology).
Technical subject matter expert accountable for planning, coordination, and execution of technical activities needed to support manufacturing operations.
POSITION DUTIES & RESPONSIBILITIES
• Maintain critical knowledge and develops best practices related to PAT;
• Support existing PAT applications deployed in manufacturing facilities, QC laboratories and development or technology support laboratories;
• Serve as a subject matter expert for instrument obsolescence projects, change control or troubleshooting activities;
• Support day-to-day operations of the PAT lab by installing and maintaining in-line analytical instruments, troubleshooting that equipment (if necessary) and ensuring proper operation of the instruments, process analyzer qualification and validation;
• Perform multivariate data/statistical analysis for method development, investigation troubleshooting, and product quality control strategy;
• Work with cross-functional stakeholders to refine business process for PAT from development to tech transfer.
• Hands on experience on a broad array of rapid spectroscopic, chromatographic, Biochemistry Analyzer including HPLC, PVM, FBRM, GC/MS, MS, Blood Gas Analyzer (BGA), YSI, Cedex Hires, Vi-CELL and other state of the art analytical instruments;
• Fundamental understanding of spectroscopic methods such as IR, FT-NIR, fluorescence, Raman, UV/VIS;
• Biopharmaceutical industry experience in process development, cGMP manufacturing, or research and discovery;
• Experience with optimizing and troubleshooting the interface between the process being measured and the analysis of the process (analytical sampling, impact of process variables on the analysis, analytical process integration, and data reporting);
• Familiarity with currently available commercial PAT technologies is expected, as is some experience with sample systems and custom instrument configurations, adaption, and repair;
• Partner with colleagues as well as external suppliers to design, develop and implement innovative on-line/in-line/at-line sensors and process analyzers;
• Technical knowledge in cell culture development and bioreactor operation.
• Hands-on experience with modern analytical instrumentation;
• Generate rational hypotheses; plan and execute laboratory experiments with proper controls, collect robust data sets and apply statistical analyses, interpret and present data before project teams;
• Provide an enhanced understanding of cell culture processes and chemical reactions in early-stage development
Minimum Education BS Degree in Chemical, Electrical, Mechanical Engineering or related discipline
B.S. 8+ years
M.S. 4+ years
Skill & Competency Requirements:
• Experience with regulatory and cGMP requirements for pharmaceutical manufacturing
• Acting as an important link between R&D and operations in implementing and securing our processes and participating in new projects;
• Hands-on experience performing analytical methods typically used in the manufacture and characterization of biological products;
• Expected to develop methods for automated process sampling and data analysis, evaluate cutting edge analytical techniques;
• Excellent interpersonal and communications skills are essential for success in this role, as are strong organizational and time management skills;
• Ability to work on multiple and simultaneous projects as part of a team in a global, fast-paced, setting where priorities may change quickly;
• Ability to simultaneously support three to five development programs, and solid method and instrument troubleshooting experience;
• Knowledge of pharmaceutical and biotech production processes as well as an excellent understanding of cGMP requirements, rules, and regulations.
• Proven ability to organize and motivate peers towards common objectives by conveying a sense of leadership and vision. Usually involves participation in and workstream leadership in cross-functional teams
• Computer savvy – proficient with CMMS (SAP), Procurement (SAP), Document Management (SCORE, ValGenesis), Change Management (SAP), Microsoft Office, and other computer/software systems.