Johnson Service Group (JSG) is seeking a Process Engineer II for our CMO life sciences, molecular diagnostics, and medical device manufacturing client in Carlsbad, CA. This is an exciting opportunity to join a growing manufacturing organization supporting innovative diagnostic and life sciences products.
Direct Hire | Onsite | $95 - $105K Summary Reporting to the Director of Technical Operations, the Process Engineer II is responsible for providing technical expertise in reagent formulation, filling, and finishing processes within a molecular diagnostics and life sciences manufacturing environment. This is a hands-on role working directly with manufacturing technicians to support process execution, technology transfer, process optimization, equipment validation, and continuous improvement while ensuring compliance with GMP and ISO 13485 quality standards. Responsibilities
Develop and validate QC and manufacturing methods
Design, specify, and validate manufacturing equipment and processes
Execute experiments to support process improvements
Transfer new methodologies into manufacturing
Troubleshoot manufacturing processes and equipment
Perform IQ, OQ, and PQ on laboratory equipment
Improve formulation, filling, and finishing processes
Support technology transfer from development to manufacturing
Develop and implement in-process manufacturing controls
Lead new product introductions (NPI) into production
Design experiments, analyze data, and prepare technical reports
Lead investigations including deviations, CAPAs, NCMRs, OOS, and OOT events
Develop production metrics and process performance indicators
Create and maintain SOPs, batch records, and work instructions
Define technical requirements for new products
Identify, qualify, and onboard laboratory and manufacturing equipment
Drive continuous improvement initiatives
Collaborate with Quality, Manufacturing, Engineering, Supply Chain, and Development teams
Qualifications
Bachelor's degree in Biology, Engineering, Computer Science, or related field
4+ years of experience in a manufacturing environment
Knowledge of ISO 13485 and GMP regulations
Strong analytical, problem-solving, and organizational skills
Excellent communication and interpersonal skills
Ability to independently manage projects and priorities
Experience working cross-functionally
Knowledge of Lean manufacturing and continuous improvement tools (Kaizen, 5 Whys, Fishbone, DMAIC, Poka-Yoke, Value Stream Mapping)
Understanding of FMEA and risk management
Experience supporting manufacturing and transferring products from R&D to production
Preferred Qualifications
Experience with organic chemistry and analytical techniques (HPLC/UPLC, MPLC, NMR)
Experience with cleanroom manufacturing or large-scale organic synthesis
Familiarity with nucleoside/nucleotide chemistry or oligo synthesis
Knowledge of Statistical Process Control (SPC) and Design of Experiments (DOE)
Experience qualifying laboratory equipment
Project management experience
*D800
** Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
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