Sr. Level CSV Engineer

Title: Sr. Level CSV Engineer
Location: NC
Exp: At least 8-12yrs

THIS IS A BACKFILL

Client is seeking an experienced CSV Engineer to support key validation activities at a leading pharmaceutical manufacturing site. The contractor will play a critical role in ensuring compliance with regulatory and company standards by providing validation and technical support throughout the lifecycle of various systems and processes.

Qualifications:
Degree:
Bachelor's degree in Engineering, Computer Science, or related technical field, or equivalent relevant work experience (required). Master's degree (MA/MS) preferred.

5 years of computer systems validation experience in a pharmaceutical environment REQUIRED
5 Years experience with regulatory requirements and industry standards including 21 CFR Part 11, GAMP5, ISO, FDA & ICH guidance documents. REQUIRED
5 Years experience w/ Root cause analysis. REQUIRED
Experience writing technical documentation based on equipment manuals. REQUIRED
Experience in GMP pharmaceutical manufacturing REQUIRED
Strong organizational skills, with the ability to manage multiple priorities and deadlines. REQUIRED
Demonstrated success in change management initiatives. REQUIRED
Experience with standard operating procedures (SOPs) and high-level conceptual understanding. PREFERRED
Project Management or Project Lead experience is a major plus. PREFERRED
Local highly preferred

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