Process Validation, Senior Validation Engineer
Job Opportunity at Clinical Dynamix, Inc.

Posted on Mar 15

http://www.clinicaldynamix.com    888-558-2546

Location: Greenville, SC
Job Type: Full Time
Job ID: W4154034

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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