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Process Validation, Senior Validation Engineer
Job Opportunity at
Clinical Dynamix, Inc.
Posted on Mar 15
Validation Engineer Process Engineer
Global Chemical /Biotech company looking to hire:
Greenville, Soth Carolina location
competitive salary and full relocation and full benefits
Would love someone who has: affiliation with: IVT (International Validation Technology), KEN X (Knowledge Exchange Network), PDA, ISPE
Remain current on cGMP practices for Process Validation and ensure local Process Validation SOPs and validation documents reflect current industry practices.
Provide validation requirements, strategy, protocols, execution and final reports for changes impacting validated products and critical process parameters.
Oversight of validation activities for R&D trials and new products.
Support engineering testing/trials and requirements for final product changes.
Creation, review, and update of risk analysis for changes and new processes that impact products.
Perform statistical analysis related to process validation.
Conduct periodic review of validated processes and equipment.
Support product annual product review.
Peer review validation studies executed by other validation team members.
Provide inputs in validation and regulatory requirement for current direct impact equipment, new equipment, and processes.
Able to self-train in new regulation and industry standards
Demonstrate enough knowledge in basic validation skills and the ability to lead change control, approve quality changes request, and other discipline protocols in lieu of the Validation Supervisor, as needed.
Required: FDA Process Validation Guidance, Statistical Sampling, Technical Writing, Use of MiniTab, product validation
Desired: Conducting and leading investigation, project management, Design of Experiments, knowledge in aseptic simulation (media fills)
Education: BS Engineering or Science
Experience - Required: 8+years Process Validation experience in Pharmaceutical, Medical Device or Parenterals. Must have experience in either an FDA or ISO Regulated Industry
Experience - Desired: Demonstrated experience and proficiency with cGXP, ICH and PIC/S. Experience with regulatory and/or third party audits
Special Skills: Strong Verbal and Written Communication; Self Driven, TEAM WORK, Result Oriented, Strong knowledge of Process Validation, Project Management, Multi-tasking, Intermediate Statistics Knowledge (sampling plans, hypothesis testing, etc), use of PFEMA risk assessment or similar, and solution aseptic filling experience
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