Employment Type : Full-Time
Job Opening for QA Validation Engineer, Greater Boston, MA
We currently working on below mentioned job opening i.,e. Job Opening for QA Validation Engineer, Greater Boston, MA. Please let me know if you are interested in applying for the same.
Job Title: QA Validation Engineer
Location the work will be performed: On-site 3 days a week, Greater Boston
Target start date: 10/03
Length of contract assignment: 6-months to start, likely extension
Work schedule: 8-5
Client description:
• Global Biotech company that currently has more than 30 programs in various stages of development. They are one of the leaders in the RNA and Gene Therapy space.
• Ton of projects on horizon and a new facility going up in MA in 2023
Project description:
Lab Expansion in Andover, MA facility. Overall, they are receiving between 50-60 pieces of equipment.
The expansion is well on it’s way, but they need more hands-on deck here as the workload is too much
for the current staff. The equipment this person will mainly be focusing on/supporting is Freezer’s,
Incubators, and HPLC’s. You will also be helping with the management of Blue Mountain.
Technology environment the consultant will be working in:
• QMS: ETQ (CAPA’s, Deviations, SOP’s)
• Veeva (Doc Mgmt)- Just went live a few months ago. Eventually CAPA’s & Deviations will be in Veeva.
Consultants day to day responsibilities:
• First two weeks:
o New hire onboarding training and reviewing SOP’s/learning processes
• Provide Quality oversight to help develop and support the validation of processes related to drug substance manufacturing
• Sign off on all qualification & validation of manufacturing and support systems
o Mostly Freezers & Incubators
o Other equipment you might work with – HPLC’s, Biosafety cabinets, and PCR’s
• Review Master Control Plans for approval, or redline deviations and discrepancies
• Apply risk management principles for qualification and remediation efforts
• Conduct bi-weekly lab walkthroughs that consist of inventory checks for verification of Blue
Mountain equipment
• Following FDA, EMEA, and ICH guidelines always
Required skills:
• Prior experience as a QA Validation Engineer/Specialist
o Reviewing/Approving designs, commissioning documents, validation, and requalification protocols
• Experience in an GLP environment, qualifying equipment using IQ, PQ, OQ protocols
o Must have worked with Freezers and Incubators before
• Extensive experience reviewing, revising, and approving Master Control Plans
• Experience interacting with regulatory agencies for all quality & validation approvals
• Must be vaccinated