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Validation Consultant

3 weeks ago

Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time
Job Title: Validation Consultant

Lynkx Staffing LLC, a leading staffing agency in New Jersey, specializes in placing professionals in the Biotechnology, Pharmaceutical and Medical Device IT & Human Resources disciplines. As a Validation Consultant, you will perform validation activities, including preparing and executing equipment protocols and preparing final reports for IQ, OQ, and PQ of cell processing and QC lab equipment.

The ideal candidate exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Key responsibilities include:
  • Preparing IQ/OQ and/or PQ protocols for various Cell Therapy manufacturing process equipment and QC test equipment.
  • Executing IQ/OQ and/or PQ protocols.
  • Preparing final reports for executed protocols.
  • Reviewing executed IQ/OQ/PQ protocols and raw data.

The role requires a Bachelor's degree in Engineering or a related Science discipline and 3-7 years of validation experience. The ideal candidate should have thorough knowledge of cGMP and regulatory requirements, including 21 CFR Part 11. Excellent protocol and report writing skills, good oral communication skills, detail orientation, problem-solving ability, and teamwork are necessary. Salary: $80,000 - $120,000 per year.