Position Details
Quality Assurance Validation Apply
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Commissioning and Validation Support:
- Review and ensure the accuracy of all documents related to facility and equipment commissioning/qualification processes.
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Compliance Oversight:
- Ensure compliance with validation protocols, supporting commissioning and validation teams in document review and deviation management.
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Operations Support:
- Collaborate with facility and equipment lifecycle teams to maintain operational standards with a focus on quality and regulatory compliance.
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Deviation Management:
- Identify, review, and resolve deviations in validation documentation to maintain high-quality standards.
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Biologics Expertise:
- Provide validation support for biologics-related processes, including working with isolators, biosafety protocols, and bioreactors.
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Quality Role in Facility Build-Out:
- Play an integral role in the build-out of the new Boston facility, supporting quality-related activities in facilities work.
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Experience: Minimum 9 years of Quality Assurance/Validation experience in facility and equipment commissioning/qualification.
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Biologics Knowledge: Strong background in biologics, including experience with isolators, biosafety protocols, and bioreactors.
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Compliance Expertise: Extensive experience with validation protocols and compliance standards within the life sciences industry.
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Document Review Skills: Strong skills in reviewing validation documents and effectively managing deviations.
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Facilities Experience: Previous experience supporting facilities projects within a quality assurance/validation role.
- Knowledge of facility control and equipment lifecycle programs.
- Experience in commissioning and qualification of new facilities, ideally in biologics manufacturing.
- Manager Reference: Each candidate submission must include one verifiable manager reference with a LinkedIn profile.
