Validation Engineer

Validation Engineer – North Billerica, MA

Work schedule/typical work week/daily start and end time:

Hours are flexible- Typically start between 7:30-9AM

Fridays remote

This individual will be a key figure in all aspects of temperature mapping and chamber requalification’s. There may be other opportunities as well for this individual to support the group as the team does have a labeler project for this year but at this time the team has indicated that they will designate full-time folks to support on this initiative.

Technology environment the consultant will be working in:

Microsoft suite, Ellab Loggers, Temperature Loggers

Consultants day to day responsibilities:

• Support the validation/technical operations team with all temperature mapping activities and chamber requalification’s
• Ensure that all validation activities are logged correctly
• Participate in qualifying equipment and commissioning activities
• Working within the ISPE guidelines and abiding by the U.S. Title 21 CFR Part 11 regulations for all electronic records

This individual will be tasked with all validation activities pertaining to the day-to-day aseptic manufacturing activities that are ongoing within the facility.