Roles & Responsbilities :
- Independently perform validation activities including installation qualification, operational qualification, performance qualification for BaseCamp projects related to facility, utilities, equipment and instrument.
- Generate protocols for tests, verification, and qualification for GxP assets, as well as reports to document execution.
- Ensure deliverables meet the overall facility milestones.
- Perform and support periodic assessment review and revalidation activities.
- Ensure deliverables are executed per ElevateBio Validation Master Plan and other required SOPs .
- Ensure discrepancies are resolved and closed out in a timely manner.
- Develop testing templates and qualification protocols using paper and electronic validation systems (Kneat).
- Perform system impact assessments, risk assessments.
- Support development and review of engineering lifecycle documents for new and existing equipment.
- Maintain the Validation Master Plan, engineering lifecycle documents, and validation program SOPs.
- Support validation activities related to tech transfer projects for all manufacturing suites.
- Support site capital projects and other improvement projects.
- Promote engineering best practices, Elevate SOPs, and cGMP regulations.
- Work with Quality Assurance to ensure all validation activities are in compliance.
- Support and execute Change Controls to qualified facilities, equipment, and utilities.
Education & Experience :
- 5+ years of experience in biotech engineering or an FDA regulated manufacturing facility.
- BS degree in engineering field or equivalent experience.
- Experience in cGMP facility / equipment start-up, commissioning, and qualification.
- Experience in cGMP processes such upstream cell expansion, downstream purification, and fill finish.
- Viral vector & Cell / Gene Therapies experience is a plus.
- Experience in using Kneat is a plus
- Strong understanding of ASTM E2500 standards for commissioning, validation, and lifecycle management of GMP equipment and systems and GxP laboratories.
- Required experience with good documentation practices and cGMP standards.
- Ability to work on multiple tasks simultaneously.
- Ability to manage priorities, deliverables, and schedule milestones.
- Strong interpersonal, verbal communication, and technical writing skills.
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