Validation Engineer II

Location: Andover, Massachusetts
Posted On: 6/12/2017
Job Code: 7782-1
Job Description
• Provide engineering and technical support related to the operation, maintenance, design, installation, startup/commissioning, testing, and qualification of production equipment and process systems within a biopharmaceutical manufacturing facility in Andover, Massachusetts. These systems may include production equipment such as bioreactors, fermenters, centrifuges, ultrafiltration skids, chromatography skids, Clean – In – Place (CIP) skids, and other support equipment.
• Support the operation and lead troubleshooting of manufacturing equipment and control systems used in the manufacture of biopharmaceuticals
• Support Tech Transfer activities for new products and product changeovers
• Support reliability engineering for production and support equipment
• Provide on the floor operational support as needed
• Lead/Support the design and qualification of improvements, changes, or upgrades to this equipment as needed
• Lead/Support the development of design and startup documents such as commissioning plans, User Requirement Specification (URS), Functional Requirement Specification (FRS), Configuration Specification (CS)
• Lead/Support the development and execution of commissioning, validation and qualification documents and activities
• Support the maintenance department as needed
• Provide equipment maintenance history review
• Support all investigations and audits as needed
• Support process and component improvement projects as needed
• Provide off-shift and on call support when necessary

• Will work as supplemental support for a team of engineers made up of both process and automation engineering. Must be able to work across functions collaboratively interacting with Quality representatives and manufacturing on a daily basis.

Additional Skills: • Support and insure the successful execution of 5 day cadence of manufacturing in Suite AB to support the 2019 shutdown
• support 5 day cadence effort. There are no exclusions or limits of work. Expectation is to be able to support as needed based on ongoing activities at the time.
Category:IT  code:new
Job Requirements
Cadence, Engineering, Technical Support, Automation

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Contact Details
Shubham B
E-mail Address