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Senior Commissioning and Qualification Engineer

Company: ElevateBio
Location: Waltham
Posted on: September 13, 2020

Job Description:

Senior Commissioning and Qualification Engineer Title: Senior Commissioning and Qualification Engineer

Location: Waltham, MA

Reports to: Senior Manager, Process Engineering

The Role

ElevateBio is looking to a Commissioning & Qualification (C&Q) Engineer to join the Process Engineering team at BaseCamp. The C&Q Engineer will manage the commissioning and qualification activities for the BaseCamp facility, utilities, and equipment. (S)he will also be responsible for developing and maintaining the engineering lifecycle documents (SIAs, URS, DRs, RAs, Plans) in accordance with industry best practices. The C&Q Engineer will continue to provide technical and C&Q support for capital projects on site working with facilities, and manufacturing, and Quality Assurance (QA) teams.

Here’s What You’ll Do:

Manage C&Q activities and deliverables to meet the overall facility milestones

Oversee external contractors and vendors during commissioning and qualification

Ensure C&Q deliverables are executed per ElevateBio Validation Master Plan and other required SOPs

Ensure discrepancies are resolved and closed out in a timely manner

Develop testing templates and C&Q protocols using paper and electronic validation systems (Kneat)

Perform system impact assessments, risk assessments, and traceability matrices

Develop engineering lifecycle documents for new equipment

Manage the Validation Master Plan, engineering lifecycle documents, and C&Q program SOPs

Support site capital projects and other improvement projects

Support periodic validation review and re-validation testing.

Promotes engineering best practices, Elevate SOPs, and cGMP regulations

Work with Quality Assurance to ensure all C&Q activities are in compliance

Manage and execute Change Controls to qualified facilities, equipment, and utilities

Requirements:

5-8 years of experience in biotech engineering or an FDA regulated manufacturing facility

BS degree in engineering field or equivalent experience

Experience in cGMP facility/equipment start-up, commissioning, and qualification

Experience in cGMP processes such upstream cell expansion, downstream purification, and fill finish. Viral vector & Cell/Gene Therapies experience is a plus

Experience in using Kneat is a plus

Strong understanding of ASTM E2500 standards for commissioning, validation, and lifecycle management of GMP equipment and systems and GxP laboratories

Required experience with good documentation practices and cGMP standards

Ability to work on multiple tasks simultaneously

Ability to manage priorities, deliverables, and schedule milestones

Requires strong interpersonal, verbal communication, and technical writing skills

Why join ElevateBio?

ElevateBio is accelerating the future of biotechnology; developing the next-generation of cell, viral and regenerative medicine therapeutics for the treatment of severe diseases. We have launched a revolutionary new model that integrates innovators, infrastructure and capital to effectively develop cell, gene and related therapies for patients with severe and life-threatening disorders. With plans for a cutting-edge laboratory and manufacturing center already underway, we're building a world-class organization lead by expert talent with bench-to-bedside capabilities. ElevateBio is also a leader in corporate philanthropy and has taken a pledge to donate a portion of product sales to fund promising cancer research and to support cancer care in the developing world.

At the heart of the ElevateBio platform is ElevateBio Base Camp, a state-of-the-art research, development and manufacturing center for innovation in the Greater Boston Area to be staffed with a world-class team of scientists.

Next-generation product development for advanced therapies supported by global bench-to-bedside expertise shared across our portfolio of companies ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Would you require visa support or sponsorship to take a position with ElevateBio? *

Would you need to relocate in order to accept a position with ElevateBio? *

Keywords: ElevateBio, Waltham , Senior Commissioning and Qualification Engineer, Other , Waltham, Massachusetts

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