Replimune, Inc. Validation Associate in Framingham, Massachusetts
The Validation Associate is responsible for the maintenance and execution of validation protocols for qualification and requalification of equipment at the Framingham, MA, manufacturing facility in accordance with appropriate regulatory guidance. The individual will work with equipment vendors and external contractors to coordinate scheduling, execution and review of qualification protocols / reports. The Validation Associate’s primary responsibility is to perform field executions for various protocols necessary for GMP equipment and systems. The individual will contribute to maintaining the validated status of the facility and equipment through calibration, performance monitoring, data integrity assessments, and requalification activities.
This position is based in our Framingham location and typically has a 5-day on-site expectation.
Revise and execute templated validation protocols for qualification and/or requalification of equipment required for cGMP compliance.
Be responsible for the execution of qualification protocol and final report generation.
Coordinate scheduling, execution & review of qualification protocols / reports.
Support / escort vendors and contractors performing qualification activities.
Perform equipment requalification to ensure utilities and equipment remain compliant with required procedures and regulations.
Review, revise and complete documentation in accordance with cGMP.
Ensure equipment and building monitoring systems remain in validated compliance and support updates as new equipment added.
Assist with trouble shooting equipment / system failures
Ensure that all work is performed in accordance with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMP), quality standards, and safety procedures
Support equipment and process related non-conformance investigations and change control activities
Ensure training is kept in GMP compliant state
At minimum, an associate’s degree or technical school certificate is required.
Bachelor’s degree in science, Technology, Engineering, and/or Math (STEM) field is preferred.
Experience and skill requirement:
A minimum of one-year relevant experience in a cGMP environment is preferred.
Excellent communication and interpersonal skills are required. Attention to detail, flexibility and technical writing skills are important for this position.
Good knowledge cGMP & GDP requirements
Ability to work independently or in a team environment as well as being self-motivated and showing initiative.
- This position is based in our Framingham location and typically has a 5-day on-site expectation.
Requisition ID: 2022-1245
External Company Name: Replimune, Inc.
External Company URL: replimune.com
Street: 33 New York Avenue