Validation Engineer II
4 days ago
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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