MES Validation Engineer Consultant - Life Sciences

Location: Southern California

Our 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 the Werum PAS-X Manufacturing Execution Systems (MES) to meet regulatory requirements and industry standards.

Responsibilities:

Generation and execution of installation, operation and performance qualification protocols for Werum PAS-X MES following risk-based approach strategy. Validation services supporting computerized system validation for the Werum PAS-X 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).

Skills and Experience:

• 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.
• 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 Werum PAS-X, or similar systems.
• Proficiency in executing validation protocols (IQ, OQ, PQ) and generating validation documentation.
• 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 Range: $75 - $90 / hour pay range is an estimate of pay for project-based employment. We recognize that talent is key to our success as a company, and aim for the most competitive compensation to ensure we are able to attract the best candidates. The quoted pay range represents our best estimate of what our ideal candidate is likely to expect, based on experience, industry knowledge, location, technical and interpersonal skills. Range varies based on knowledge and experience.

Join our team as an MES Validation Engineer Consultant and contribute to the advancement of life-saving cell and gene therapies. This consulting role offers an exciting opportunity.