Validation Specialist

US$70 - US$90 per hour

On-siteEngineeringContractUSClayton, North Carolina

Validation Specialist - Pharmaceutical Equipment Testing

Location: Clayton
Contract Type: Fixed-term, contractor-based
Rate: Competitive, dependant on experience

Role Overview:
Our client, a leading organization in the pharmaceutical industry, is seeking 1-2 experienced Validation Specialists to join their team on a contractual basis. These roles focus on the planning, drafting, and execution of testing for API pharmaceutical equipment in an operating pharmaceutical environment.

Key Responsibilities:
The successful candidates will have a strong background in pharmaceutical equipment testing, with expertise in:

  • Performing change management (electronic systems).
  • Conducting riboflavin testing for spray coverage validation.
  • Executing cleaning validation processes.
  • Performing Installation Operational Verification (IOV) testing.
  • Thermal mapping of fermenters or large tank vessels.
  • Ensuring successful Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) procedures.
  • Drafting and executing engineering studies and validation tests.
  • Working with Safety Relief Valve (SRV) systems.
  • Hands-on experience with fermentation processes, especially fermenter equipment.
  • Drafting and updating Standard Operating Procedures (SOPs).

Required Knowledge/Experience:
Candidates should have proven expertise in:

  • Testing and validating pharmaceutical equipment in operational environments.
  • Meeting industry and regulatory standards for pharmaceutical processes.

Required Skills/Qualifications:

  • 5-8 years of professional experience in pharmaceutical equipment testing and validation, with a preference for candidates exceeding this range.
  • Demonstrated ability to draft and execute complex engineering studies and validation tests.
  • Strong analytical skills and attention to detail in process validation.
  • Excellent communication skills, with the ability to draft clear and comprehensive SOPs.

Preferred Qualifications:

  • Advanced knowledge of fermentation processes and related equipment.
  • Expertise in thermal mapping and validation of large vessels and fermenters.

Job Level:
This position is suitable for senior professionals with:

  • 5-8 years of experience, with a preference for those exceeding 8 years.

Why Join Our Client?
This role offers an exciting opportunity to contribute to cutting-edge pharmaceutical projects within a highly respected organization. By joining the team, you will enhance your career while directly supporting innovation in pharmaceutical manufacturing processes.

How to Apply:
If you meet the requirements and are eager to make a significant impact, submit your resume and cover letter highlighting your relevant experience and qualifications.

Our client is an Equal Opportunity Employer committed to diversity and inclusion in the workplace.

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