Process Engineer II

Process Engineer II

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.

Job Description

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.