Validation Expert

2 weeks ago


Raleigh, North Carolina, United States Advanced Recruiting Partners Full time
Job Title: Validation Specialist

Job Summary:

We are seeking a highly skilled Validation Specialist to join our team at Advanced Recruiting Partners. As a key member of our team, you will be responsible for providing validation services required for the successful delivery of IT & Automation projects.

Key Responsibilities:

  • Provide validation & technical support through the preparation, execution, data analysis, & report writing for IV, OV & PV protocols.
  • Ownership of Change Requests (CR's) related to project validation responsibilities.
  • Perform compliance & technical reviews/approvals of protocols & protocol data.
  • Author project quality masterplans (PQMP's), validation plans (VPL's), & other key validation documentation.
  • Author & execute assigned IV, OV & PV protocols for direct impact systems/processes per approved timeframes.
  • Ensure compliance of validation protocols executed are aligned with local, corporate & regulatory regulations.
  • Lead validation failure investigations & non-conformities utilizing root cause analysis techniques.
  • Create & modify existing validation procedures & configuration item lists (CIL's) as required.
  • Write/Review specifications, procedures, & other required supporting documents to maintain the validated state of equipment & processes.
  • Participate in FAT, SAT commissioning efforts for equipment, automation systems & processes & successfully transition into the ownership role for validation efforts related to the equipment.
  • Identify process improvements before equipment, systems or processes are placed under change control during validation.
  • Budget oversight as needed.
  • Contractor scheduling & oversight as needed.
  • Leads validation activities assigned by overall project manager.

Requirements:

The ideal candidate will have a strong background in validation and technical support, with excellent communication and problem-solving skills. They will be able to work independently and as part of a team, with a strong attention to detail and ability to meet deadlines.

What We Offer:

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced Validation Specialist looking for a new challenge, please submit your application.


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