Experience with Isolators, Bioreactors, Biosafety, and Biologics Equipment
Position Overview:
We are seeking an experienced Quality Assurance Validation (QAV) Specialist with a minimum of 9 years of experience to support facility and equipment commissioning/qualification activities. The role will be based onsite at a newly acquired facility in the Seaport area of Boston. The successful candidate will also support operations and facility control, as well as equipment lifecycle programs.
This is an exciting opportunity to be part of a long-term project involving the buildout of a 7-story facility over the next 3 years. The ideal candidate will have experience in a quality role, particularly within biologics manufacturing environments.
Key Responsibilities:
Provide quality oversight and support for facility commissioning and validation activities.
Review all associated documents related to validation and commissioning to ensure accuracy and compliance.
Manage and resolve any deviations found in validation documentation.
Ensure compliance with regulatory protocols, particularly in a biologics environment.
Work closely with the commissioning and validation team to maintain compliance and quality standards throughout the project.
Support facility control and equipment lifecycle management.
Work with isolators, bioreactors, biosafety, and biologics-related equipment, providing expert insight on quality requirements.
Qualifications:
Minimum of 9 years of experience in Quality Assurance roles, with a focus on commissioning and validation in biologics or pharmaceutical facilities.
Proven experience with facilities work within a quality assurance role, particularly in biologics environments.
Strong compliance experience, including knowledge of validation protocols.
Ability to review validation documentation and sort out deviations effectively.
Familiarity with biologics, isolators, biosafety, and bioreactors is highly preferred.