Process Engineer II

Process Engineer IIJohnson 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 DescriptionReporting 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 methodsDesign, specify, and validate manufacturing equipment and processesExecute experiments to support process improvementsTransfer new methodologies into manufacturingTroubleshoot manufacturing processes and equipmentPerform IQ, OQ, and PQ on laboratory equipmentImprove formulation, filling, and finishing processesSupport technology transfer from development to manufacturingDevelop and implement in-process manufacturing controlsLead new product introductions (NPI) into productionDesign experiments, analyze data, and prepare technical reportsLead investigations including deviations, CAPAs, NCMRs, OOS, and OOT eventsDevelop production metrics and process performance indicatorsCreate and maintain SOPs, batch records, and work instructionsDefine technical requirements for new productsIdentify, qualify, and onboard laboratory and manufacturing equipmentDrive continuous improvement initiativesCollaborate with Quality, Manufacturing, Engineering, Supply Chain, and Development teamsQualifications:Bachelor's degree in Biology, Engineering, Computer Science, or related field4+ years of experience in a manufacturing environmentKnowledge of ISO 13485 and GMP regulationsStrong analytical, problem-solving, and organizational skillsExcellent communication and interpersonal skillsAbility to independently manage projects and prioritiesExperience working cross-functionallyKnowledge of Lean manufacturing and continuous improvement tools (Kaizen, 5 Whys, Fishbone, DMAIC, Poka-Yoke, Value Stream Mapping)Understanding of FMEA and risk managementExperience supporting manufacturing and transferring products from R&D to productionPreferred Qualifications:Experience with organic chemistry and analytical techniques (HPLC/UPLC, MPLC, NMR)Experience with cleanroom manufacturing or large-scale organic synthesisFamiliarity with nucleoside/nucleotide chemistry or oligo synthesisKnowledge of Statistical Process Control (SPC) and Design of Experiments (DOE)Experience qualifying laboratory equipmentProject 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.