QA Validation Engineer

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

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