MES Validation Engineer Consultant
1 week ago
Valspec, a global provider of system validation and lifecycle services, is seeking a skilled MES Validation Engineer Consultant to support its organization on a consulting basis. This role will play a critical part in ensuring the successful validation of the Werum PAS-X Manufacturing Execution Systems (MES) to meet regulatory requirements and industry standards.
Key Responsibilities:
- Develop and execute validation protocols (IQ, OQ, PQ) for MES systems, ensuring they are thorough, accurate, and in accordance with established procedures.
- Collaborate with cross-functional teams to develop a comprehensive validation strategy for MES systems, aligning with regulatory requirements, industry best practices, and company policies.
- Assist with development of validation schedule, coordinating activities with internal teams and external vendors.
Requirements:
- Previous design/validation experience in Werum PAS-X (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.
Valspec offers a standout culture, fantastic work environment, and has very competitive benefits to include premium medical, 401K match, profit sharing, tuition reimbursement, and other unique incentives.
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