Process Engineer II

Argonaut Manufacturing Services•Carlsbad, CA

22h•Onsite

About The Position

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.

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

Nice To Haves

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

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