Pharmaceutical Validation Specialist
4 weeks ago
As a highly skilled Validation Engineer at Spark Life Solutions, Inc., you will serve as the primary Commissioning & Verification (C&V) Subject Matter Expert for one of four project work streams. You will be responsible for ensuring that all commissioning and verification activities are conducted in accordance with the ASTM E2500 standard and Good Manufacturing Practices (GMP) requirements.
Main Responsibilities:
- Collaborate with leadership and other stakeholders to establish priorities and define commissioning and verification requirements for the assigned work stream.
- Develop and execute verification documentation in accordance with Pharmaceutical Quality Standards and cGMP requirements.
- Review and assess vendor documentation and executed testing for adherence to GMP and project requirements.
- Lead and participate in development of complete verification documentation, including documentation of critical aspects, risk assessments, verification testing strategy, and acceptance criteria.
- Collaborate with other work stream leads to ensure effective integrated verification strategy of integrated systems and equipment.
- Maintain a working familiarity with current industry best practices and cGMP requirements, and stay up-to-date on the latest techniques for project management and pharmaceutical processing technology.
- Assist in the preparation of C&V status reports, including descriptions, justifications, cost estimates, budgets, schedules, analysis of alternatives, verification requirements, and other required information.
Requirements:
- Minimum 4 years of technical experience in a pharmaceutical or FDA-regulated manufacturing environment.
- Demonstrated understanding of cGMP and facility/equipment validation requirements.
- Excellent oral and written communication skills, including presentations.
- Ability to work effectively with all levels of the organization and to write clearly, concisely, and persuasively in a professional environment.
Education:
Bachelor of Science in a technical field (engineering, life science, or equivalent) from an accredited institution.
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