Validation Engineer II

4 days ago


Framingham, Massachusetts, United States Proclinical Staffing Full time
Validation Engineer II

Proclinical is collaborating with a biotechnology company to seek a skilled Validation Engineer II for a role based in Framingham, MA. The ideal candidate will have experience in establishing and maintaining validation plans and procedures for equipment qualification, ensuring compliance with regulatory guidance.

Key Responsibilities:

  • Develop and implement validation plans and procedures for equipment qualification.
  • Coordinate with customers and external contractors to manage validation campaigns.
  • Maintain the validated status of the facility and equipment.
  • Ensure compliance with cGMP and GDP requirements.
  • Collaborate with project teams for new equipment and facility expansion projects.

Requirements:

  • BS in Scientific, Engineering, or a similar subject.
  • Professional experience in validation, engineering, or operations.
  • Relevant experience in a cGMP environment is preferred.
  • Experience with GxP Computer System Validation (CSV) on SaaS platforms.
  • Familiarity with GMP utilities and equipment is preferred.
  • Excellent communication and interpersonal skills.
  • Attention to detail, flexibility, and technical writing skills.

About Proclinical Staffing:

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

We are an equal opportunity employer and welcome applications from qualified candidates.


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