MES Validation Engineer

Overview

Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec’s mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals. The client is a leading life sciences company specializing in cell and gene therapy, dedicated to revolutionizing healthcare through innovative treatments. We are seeking a skilled and experienced MES Validation Engineer Consultant to support our organization on a consulting basis. In this role, you will play a critical part in ensuring the successful validation of Tulip Manufacturing Execution Systems (MES) to meet regulatory requirements and industry standards. Responsibilities

Generation and execution of installation, operation and performance qualification protocols for Tulip MES following risk-based approach strategy. Validation services supporting computerized system validation for the Tulip Manufacturing Execution System. Validation Strategy and Planning : Collaborate with cross-functional teams to develop a comprehensive validation strategy for MES systems, aligning with regulatory requirements, industry best practices, and company policies. Define validation deliverables, including validation plans, protocols, and reports, ensuring they are following relevant regulations (e.g., FDA regulations, GMP guidelines, 21 CFR Part 11). Assist with development of validation schedule, coordinating activities with internal teams and external vendors. Validation Execution and Documentation : Perform risk assessments and impact analyses to identify critical aspects and functionalities of MES systems requiring validation. Develop and execute validation protocols (IQ, OQ, PQ) for MES systems, ensuring they are thorough, accurate, and in accordance with established procedures. Generate validation reports and summaries, documenting test results, deviations, and corrective actions. Generation and investigation of protocol exceptions. Generation of qualification final reports and traceability matrices. Review and evaluate vendor-provided documentation, including user requirements, functional specifications, and design documents. Documentation updates (SOPs, Forms, and other documents). Qualifications

Previous design / validation experience in Tulip (Master Batch Records, Electronic Batch Records, Review by exception). Proficient in computer system validation. Bachelor’s degree in engineering, computer science, or a related field. Extensive experience (minimum 5 years) in validation of MES systems within a regulated manufacturing environment in the life sciences or biotechnology industry. In-depth knowledge of regulatory requirements, industry standards, and guidelines related to MES systems validation, such as FDA regulations, GMP guidelines, and 21 CFR Part 11. Strong understanding of MES concepts, functionalities, and system integration principles. Familiarity with MES software platforms, such as Tulip, or similar systems. Strong analytical and problem-solving skills, with the ability to identify and mitigate validation risks. Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams. Pay and Benefits

Pay Range : $75 - $90 / hour. The range is an estimate for project-based employment. We aim to offer competitive compensation to attract top candidates. The quoted pay range represents our best estimate based on experience, industry knowledge, location, technical and interpersonal skills. Range varies based on knowledge and experience. Valspec offers a standout culture, fantastic work environment, and competitive benefits including premium medical, 401K match, tuition reimbursement, and other incentives. Equal Opportunity Employer : Valspec is committed to providing a professional environment free of discrimination or harassment. We are a Drug-Free Workplace. Important notice : When receiving emails from a Proconex or Valspec recruiter, only emails from addresses ending in @proconexdirect.com or @valspec.net are legitimate. Other domains should be ignored.

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