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20 days old

Validation Engineer

Kelly Services
Worcester, MA 01613
Validation Engineer (Worcester, MA)


Our client in biologics manufacturing is currently hiring a Validation Engineer (Experienced Validation Engineer needed to provide ownership and expertise of validation activities in the Quality Control laboratory in Worcester, MA).


The Validation Engineer will be responsible for commissioning and qualification activities associated with capital projects involving the installation and/or renovation of biopharmaceutical process equipment, facilities, and utilities in an FDA/GMP regulated environment. The engineer will work in a multi-disciplinary team environment.


This position is a Contract without an end date. For the right candidate is a Permanent role on staff a possibility? Absolutely!! Will you have medical options while Contracting with Kelly Engineering? YES again!


Primary Responsibilities:

Prepare validation test protocols, set validation strategy, perform/coordinate validation testing for capital projects of different complexity in concert with all stakeholders, and analyze/assemble test results to create summary reports as required.

Review new equipment specifications.

Work with appropriate departments and personnel to resolve validation testing issues.

Advise other departments on SOPs related to validation projects.

Maintain 100% on time training.

Execute assigned jobs and tasks according to schedule.

Achieve Site, Department and Group performance metrics.

Complete other special projects and assignments as required.

Comply with all regulatory, corporate, and site quality system procedures, especially safety and cGMPs.


Education:

BS/MS Degree in engineering, technical discipline or equivalent preferred, with a minimum 3 years experience supporting biologics manufacturing through validation of biologics equipment or processes.

All levels of experience will be considered (Client may look at Quality Engineer I, Quality Engineer II or Quality Engineer III experience levels).


Background:

Prior experience working in Quality Control or R&D labs is preferred.

An understanding of basic unit operations involving cell culture and protein purification is desired.

Working knowledge of bioreactors, sanitary equipment, hygienic piping, process instrumentation and controls is required.

Expertise in Clean-In-Place and Steam-In-Place theory and techniques is preferred.

Experience with risk-based approach to commissioning and qualification preferred.

Experience with temperature mapping of environmental chambers, autoclave validation is strongly required.

Familiarity with distributed control systems and process logic controllers is required.

Must have familiarity with P&IDs, loop diagrams, etc.

Must have hands-on experience on the Kaye Validator.

Familiarity with project management is preferred.

Experience with risk assessment and system classifications is a plus.

Adherence to cGMP and GDP is required.

Strong technical writing skill is required.

Strong organizational, prioritization, technical, mechanical, and communication skills as well as experience in a GMP environment are preferred.


Entry Level candidates will also be considered, provided they have at least one year strong validation experience.


\#TJP2022_SPEC


**Why Kelly** **** **Engineering?**


Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the worlds most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, were here to guide you to the next step in your engineering career.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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Posted: 2022-09-14 Expires: 2022-10-15

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Validation Engineer

Kelly Services
Worcester, MA 01613

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