Validation Engineer - Spark Life Solutions Inc

Job Title:- Validation Engineer

Location: Kalamazoo, MI

Roles & Responsibilities:

• Serve as the primary Commissioning & Verification (C&V) Subject Matter Expert for one of four project work streams. Commissioning and Verification (aka Qualification) will follow the ASTM E2500 standard.
• Effectively interact with leadership and partner with C&V Lead, Engineering Project Management, Automation, Maintenance, Operations, and Quality stakeholders to establish priorities and define the commissioning & verification requirements for the assigned workstream. This would include documentation of critical aspects, risk assessments, verification testing strategy, and acceptance criteria.
• Review of technical specification documents, drawings, and vendor design submittals (including FAT, SAT, IQ/OQ), with a specific focus on GMP-critical aspects and impact on commissioning & verification.
• Review and assess vendor documentation and executed testing (e.g. FAT, SAT) for adherence to GMP and project requirements.
• Lead and participate in development and execution of complete verification documentation in accordance with Pharmaceutical Quality Standards, cGMP requirements, and approved verification requirements / strategy related to the assigned work stream.
• Collaborate with other work stream leads to ensure effective integrated verification strategy of integrated systems and equipment.
• Provide or arrange for development of complete verification documentation in accordance with Pharmaceutical Quality Standards and cGMP requirements for assigned work stream.
• Collaborate with matrix organization to optimize Change Control implementation and management.
• Maintain a working familiarity with current industry best practices and cGMP requirements. Maintain technical skills in the latest techniques for project management and pharmaceutical processing technology.
• Assist C&V Lead with the preparation of C&V status reports: include descriptions, justifications, cost estimates, budgets, schedules, analysis of alternatives, verification requirements, and other required information.
• Must be willing to work onsite in Kalamazoo, MI
• Bachelor of Science in Technical Field (engineering, life science, or equivalent) from accredited institution.

Education & Experience:

• Minimum 4 years technical experience.
• Experience in a pharmaceutical / FDA-regulated manufacturing environment. A solid working knowledge of cGMP and facility/equipment validation requirements.
• Communication Skills: Excellent oral and written communication skills, including presentations.
• Ability to write clearly, concisely, and persuasively in a professional environment.
• Demonstrated ability to interact effectively with all levels of the organization.
• Demonstrated understanding of risk-based approach to commissioning & qualification.