Senior Validation Engineer
Brammer Bio
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Post Date: Oct 02, 2017
Job Type: Full time
Degree Requirement: Bachelors
Years Experience: 10+
Location: US - Massachusetts - Boston
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Description
Sr Validation Engineer I reporting directly to the Commissioning, Qualification and Validation (CQV) manager. Responsible for the commissioning, qualification and validation of facilities, utilities and equipment systems associated with cGMP biopharmaceutical contract manufacturing and development organization (CDMO) site. Clinical or commercially licensed gene therapy products are in scope for the site.
Subject matter expert for performing site change control validation impact assessments and supporting deviations associated with facilities, utilities and process equipment. Generate, execute and close-out commissioning test plans and/or validation protocols required as part of change control. Actively manage resources associated with test plan and/or protocol execution. Investigate validation execution failures and provide impact justification for CAPAs and deviations. Generate validation-related reports and project plans associated with tech transfer and other site projects/initiatives. Generate validation master plans associated with CQV department philosophy. Design and execute process and cleaning validation studies meeting site and industry standards. Assist with product changeovers, troubleshooting investigations and continuous improvement initiatives. Mentor junior validation associates in the CQV department. Maintain CQV department and corporate training targets.


Skills
A B.S. degree in mechanical engineering, biochemical engineering, chemical engineering, electrical engineering or related engineering field and 10 years of appropriate CQV experience in a cGMP manufacturing environment.

Additional experience and qualification requirements include the following:

•        Extensive knowledge of validation activities, including protocol generation, execution and final report approval/closeout.
•        Extensive knowledge of change control and performing validation impact assessments.
•        Strong interpersonal and communication skills.
•        Strong understanding of applicable regulatory requirements (FDA and EMA).
•        Strong understanding of industry standards for commissioning and validation of facilities, utilities and process equipment for cGMP manufacturing.
•        Strong understanding of ASTM E2500 CQV lifecycle model.
•        Excellent technical writing skills.
•        Strong experience in equipment design, installation and start-up.
•        Strong experience with performing facility qualification, including environmental monitoring (EM) testing for process cleanrooms (ISO and EU classification).
•        Strong experience with performing utility qualification for the following systems: WFI, purified water, clean steam, process gasses, HVAC, vaporized hydrogen peroxide (VHP), CIP, Chilled Glycol, Wastes, etc.
•        Strong experience with performing equipment qualification for the following systems: bioreactors, depth filters, mix tanks, autoclaves, chambers, chromatography, tangential flow filtration (TFF), drug product filler/isolator, etc.
•        Experience with the qualification of single use technology is desired.
•        Experience with the qualification of VHP systems is desired.
•        Experience with the qualification of a drug product fill line (including isolator, drug product filler, label, inspection and pack) is desired.

Notes
Brammer Bio, LLC is a dynamic gene and cell therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients. Our staff members; are committed to making a difference in our organization, for our client partners and the patients we serve. We seek individuals with proven competencies and strong character to help lead our organization now and into the future.
Our company offers a full benefit package including healthcare, personal time off and an incentive bonus plan.



Contact Details
Name: Brammer Bio MA, LLC
Department: Engineering & Validation
Address: 250 Binney Street
State/Province: Massachusetts
Country: United States
Ph: 3864188199
FAX: 3864188199
URL: https://www.brammerbio.com/careers