Process Engineer II, Life Sciences Industry (Direct Hire)

Process Engineer II

Carlsbad Area

This position reports to the Director of Technical Operations and will be responsible for providing expertise and guidance in the field of reagent formulation, filling and finishing activities for the Molecular Diagnostics & Life Sciences manufacturing segment of Argonaut Manufacturing Services. This individual will be hands-on and be directly involved with floor technicians to ensure proper techniques and guidelines are being followed.

This role is an on-site position Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 7:00 am - 9:00 am with a consistent schedule.

Duties and Responsibilities

• Develop and validate methods associated with QC and Manufacturing processes
• Design, specify and validate equipment and processes
• Design and execute experiments to support process changes
• Facilitate transition of new methodologies into manufacturing laboratory
• Troubleshoot existing processes and provide guidance on potential enhancements
• Perform IQ, OQ, and PQ for laboratory instruments
• Respond to process and instrument failures to minimize downtime
• Improve formulation processes and procedures
• Review and support the transfer of client process steps for formulation/filling and improve, when possible
• Responsible for development and implementation of production and analytical "In-process" controls for commercial manufacturing
• Responsible for leading and executing transfer of NPIs from development to manufacturing shopfloor
• Responsible for independently designing and executing experimental protocols, interpreting data from different sources/format and preparing scientific/operations development reports
• Effective communication with all levels of organizational structure, through multiple departments
• Responsible for leading quality investigations like deviations, CAPAs, NCMRs, OOS, OOT issues
• Take initiative to develop and implement new processes to collect data around and analyze the health of production areas
• Create and format technical documents like SOPs, master batch record and work instructions
• Assist in defining technical requirements for new products
• Responsible for identifying and on-boarding laboratory/floor equipment
• Characterize and develop key metrics to drive efficiency and robustness improvements in product development
• Collaborate with Development, Equipment engineering, Quality, Manufacturing, supply chain, and other departments as needed to address issues with and set appropriate specifications for manufactured products

Qualifications and Requirements

• Bachelor's degree in Biology, Engineering, or Computer Science or related field and 4 or more years of experience in industrial setting
• Knowledge of ISO 13485 Quality Management System and GMP
• Must be meticulous and organized with excellent problem solving and analytical skills
• Effective interpersonal and communication skills
• Self-starter who can independently drive projects and day-to-day work tasks to completion while staying on schedule
• Must work cross functionally with team
• An understanding of LEAN practices and the use of continuous improvement tools like Kaizen, 5 why's, fishbone diagrams, DMAIC, poka yoke, value stream mapping
• Understanding of FMEA and risk management
• Experience in organic chemistry, chromatography (HPLC/UPLC, MPLC), NMR and other analytical techniques used in organic synthesis is preferred
• Experience in large scale organic synthesis, clean room manufacturing is a plus
• Familiarity with nucleoside/nucleotide chemistry, oligo synthesis is preferred
• Familiarity with Statistical Process Control and DOE techniques is preferred
• Experience in manufacturing support/sustaining and transferring products from R&D to production preferred
• Experience in laboratory equipment identification and on-boarding is a plus
• Experience with project management and associated organization tools is a plus