Analytical Validation Engineer / 61338
Payrate up to $57/HR DOE
Monday – Friday, 8 AM – 5 PM | Occasional Weekends (Approx. 1 per Quarter)

Sapphire Recruitment is seeking an Analytical Validation Engineer for a long-term contract position supporting systems validation activities within a GMP-regulated environment. This role will focus on validation of automation and enterprise systems and offers exposure to cutting-edge digital plant technologies.

Key Responsibilities:

• Develop and execute Computer System Validation (CSV) documents including plans, requirements, protocols (IQ/OQ/PQ), and summary reports.

• Support validation of automation systems, manufacturing execution systems, and enterprise platforms.

• Monitor IT service management tickets and ensure documentation compliance.

• Collaborate across departments to identify and resolve process gaps and ensure regulatory alignment.

• Contribute to data integrity, audit trail reviews, user access controls, and traceability assessments.

Qualifications:

• Bachelor’s degree in Engineering, Computer Science, or related technical field preferred (Associate degree with 1–3 years of GMP experience accepted).

• Strong understanding of GAMP and 21 CFR Part 11 compliance.

• Proficiency in technical writing and documentation development.

• Prior experience with system validation (CSV) and regulated environments preferred.

• Familiarity with building automation, MES, or enterprise systems is a plus.

• Ability to manage multiple projects, meet deadlines, and work both independently and as part of a team.

Additional Details:

• Position is onsite and may transition to a hybrid model.

• Occasional weekend work may be required.

• Must be comfortable working in both office and controlled environments with appropriate PPE.

Sapphire Recruitment is an Equal Opportunity Employer.

Submit resumes to mfgresume@hiresapphire.com for immediate consideration.

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