Katalyst CRO
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Manufacturing engineer
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Katalyst CRO 2 days ago Be among the first 25 applicants Join to apply for the
Manufacturing engineer
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Katalyst CRO Get AI-powered advice on this job and more exclusive features. 5 to 6 years of medical devices or diagnostic equipment manufacturing experience. Manage the end-to-end validation documentation lifecycle including authoring, reviewing and approving protocols (URS, IQ, OQ, PQ, PV, TMV, RTM, VSR) Change Controls and Periodic Reviews, ensuring alignment with site VMP and ISO 13485. Lead cross-functional validation initiatives for lab equipment, facilities, and non-product software supporting molecular diagnostics platforms. Qualify GXP equipment in compliance with FDA 21 CFR Part 11, 211. Support entire equipment lifecycle from qualification till decommissioning. Collaborated with QA and manufacturing teams to conduct deviation management and QI/ CAPA investigations, executing root cause analysis (5 Whys Fishbone). Applied statistical tools (ANSI/ASQ Z1.4 sampling plan) and tools such as Normality test, Distribution analysis, control charts and to support method validation, trending and ensure process robustness. Apply GAMP5 risk-based validation framework for assessing and validating non product software systems used in quality and manufacturing environments and authoring NPSW documentations. Driving agile change control process for release of agile production documents. Ability to interface with View Linc and Vaisala systems for obtaining environmental monitoring data for validation and QMS use. Conduct gap analyses on method validation processes, environmental monitoring, and equipment qualification, aligning them with industry and regulatory standards. Supporting VRB meetings, documenting validation metrics, tracking goals and addressing escalation for resolution. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Manufacturing Engineer jobs in
San Diego, CA . Manufacturing Engineer (Associate or Mid-level)
Manufacturing Engineer (Associate or Mid-level)
San Diego, CA $80,750.00-$129,950.00 5 hours ago Tijuana, Baja California, Mexico 1 month ago Sr. Mechanical Engineer (Must Have Injection Molded And Sheet Metal Part Design)
Poway, CA $80,000.00-$100,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Manufacturing engineer
role at
Katalyst CRO 2 days ago Be among the first 25 applicants Join to apply for the
Manufacturing engineer
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. 5 to 6 years of medical devices or diagnostic equipment manufacturing experience. Manage the end-to-end validation documentation lifecycle including authoring, reviewing and approving protocols (URS, IQ, OQ, PQ, PV, TMV, RTM, VSR) Change Controls and Periodic Reviews, ensuring alignment with site VMP and ISO 13485. Lead cross-functional validation initiatives for lab equipment, facilities, and non-product software supporting molecular diagnostics platforms. Qualify GXP equipment in compliance with FDA 21 CFR Part 11, 211. Support entire equipment lifecycle from qualification till decommissioning. Collaborated with QA and manufacturing teams to conduct deviation management and QI/ CAPA investigations, executing root cause analysis (5 Whys Fishbone). Applied statistical tools (ANSI/ASQ Z1.4 sampling plan) and tools such as Normality test, Distribution analysis, control charts and to support method validation, trending and ensure process robustness. Apply GAMP5 risk-based validation framework for assessing and validating non product software systems used in quality and manufacturing environments and authoring NPSW documentations. Driving agile change control process for release of agile production documents. Ability to interface with View Linc and Vaisala systems for obtaining environmental monitoring data for validation and QMS use. Conduct gap analyses on method validation processes, environmental monitoring, and equipment qualification, aligning them with industry and regulatory standards. Supporting VRB meetings, documenting validation metrics, tracking goals and addressing escalation for resolution. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Manufacturing Engineer jobs in
San Diego, CA . Manufacturing Engineer (Associate or Mid-level)
Manufacturing Engineer (Associate or Mid-level)
San Diego, CA $80,750.00-$129,950.00 5 hours ago Tijuana, Baja California, Mexico 1 month ago Sr. Mechanical Engineer (Must Have Injection Molded And Sheet Metal Part Design)
Poway, CA $80,000.00-$100,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr