Manufacturing Technical Support Specialist/Deviations Specialist
Listed on 2026-09-22
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Manufacturing / Production
Validation Engineer, Quality Engineering, Pharmaceutical Manufacturing, Production QC/QA
Manufacturing Technical Support / Deviations Specialist
Duration: 2+ Years
Pay Rate: $48–$52/hr on W2
Job Summary:Seeking an experienced Manufacturing Technical Support/Deviations Specialist to provide on-the-floor technical support, troubleshooting, deviation management, and process improvement for cGMP biologics manufacturing operations.
Key Responsibilities:- Provide real-time troubleshooting and rapid-response support for manufacturing issues.
- Lead/support deviations, investigations, CAPAs, change controls, root-cause analysis, and product/process impact assessments
. - Author and revise SOPs, batch production records, technical reports, and GMP documentation
. - Support upstream mammalian cell culture and downstream purification
, including chromatography, TFF/filtration, bioreactors, buffer/solution preparation, and single-use systems. - Support mRNA/molecular therapeutics and small-scale fill/finish manufacturing activities.
- Support technology transfer, facility fit, process scale-up, PPQ/late-phase, and commercial manufacturing programs
. - Analyze manufacturing/process data, identify trends and out-of-spec/aberrant results, and recommend corrective actions.
- Evaluate equipment/process performance and drive continuous improvement, efficiency, consistency, and waste-reduction initiatives
. - Work cross-functionally with Manufacturing, Process Development, QA, QC, Supply Chain, Engineering/Facilities, and Project Management
. - Provide technical support during client meetings and communicate project/process status.
- Support cleanroom manufacturing and ensure compliance with cGMP, site SOPs, and regulatory requirements
.
Track Wise, Compliance Wire, Unicorn, MS Excel, Word, Project, and Visio.
Benefits:This a contract position does not include employer-provided benefits.
Equal OpportunityEmployer:
We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to
race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Background checks may be conducted in accordance with applicable law.
Work Authorization:Applicants must be authorized to work in the United States
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