Validation Engineer
Brammer Bio
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Post Date: Oct 02, 2017
Job Type: Full time
Degree Requirement: Bachelors
Years Experience: 2+
Location: US - Massachusetts - Boston
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Description
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.
Generate, execute and close-out commissioning test plans and/or validation protocols required as part of change control. Investigate validation execution failures and provide impact justification for CAPAs and deviations. Design and execute process and cleaning validation studies meeting site and industry standards. Assist with product changeovers, troubleshooting investigations and continuous improvement initiatives. Maintain CQV department and corporate training targets.


Skills
B.S. degree in mechanical engineering, biochemical engineering, chemical engineering, electrical engineering or related engineering field and 2-3 years of appropriate CQV experience in a cGMP manufacturing environment.

Additional experience and qualification requirements include the following:

•        Knowledge of validation activities, including protocol generation, execution and final report approval/closeout.
•        Knowledge of change control and performing validation impact assessments.
•        Strong interpersonal and communication skills.
•        Strong technical writing skills.
•        Experience with performing facility qualification, including environmental monitoring (EM) testing for process cleanrooms (ISO and EU classification).
•        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.
•        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.

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