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.

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