1+ months

Validation Engineer

Kelly Services
Buena, NJ 08310


Kelly Engineering is currently recruiting for a Validation Engineer with experience in the Medical Device industry for a position in Buena, NJ. You will be expected to establish validation standards, develop FMEA documents and Validation Test Protocols, evaluate equipment, document test results and coordination of the equipment validation program. You will coordinate with other personnel or departments who will be affected by validation and testing. You will handle the development of Process/Equipment FMEAs as well as develop and execute IQ/OQ/PQ documents for equipment, cleaning and test method validations. You will coordinate the Master Validation Plan Evaluation of validated equipment to determine if equipment needs to be repaired or replaced. You will perform FATs as needed and provide technical expertise for acceptance test on site. You will provide equipment, facilities/utilities qualification guidance and strategy during project planning and development phases as well as contribute to GMP systems improvements. You will train operations staff on protocols, procedures and technical details related to systems, equipment and cleaning processes. You will organize and present qualification data, results, documentation and reports within the appropriate equipment/system validation files and system manuals. You will update and maintain Qualification Program SOPs, forms, records to meet cGMPs and local, state and federal regulatory requirements. You will assist with the development of URS and detailed technical specifications for manufacturing, packaging and utility equipment. You will serve as SME for metrology development projects and Measurement System Evaluations.

**NOTE: This company does not offer H-1B or any other work authorization visa sponsorship for this position. Candidates must be legally authorized to work in the United States at the time of hire and maintain work authorization throughout the employment term**

Qualified candidates will have the following education/experience to be considered:

*Minimum of a Bachelor s degree in an Engineering discipline such as mechanical, electrical engineering. A computer science background is also preferred.

*Minimum of 3-5 years Validation Engineering experience in the medical device industry

*Strong experience with FMEA's and IQ/OQ/PQ documents

*Strong mechanical, math and science aptitude, technical writing skills, knowledge of medical device manufacturing and preventive maintenance methods, deep understanding of statistical methods.

*Ability to read and analyze User Requirement Specification URS and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.

*Ability to write reports, business correspondence, and procedure manuals.

*Ability to effectively present information and respond to questions from groups of managers, clients, customers.

*Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

*Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.

*Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

**NOTE: This company does not offer H-1B or any other work authorization visa sponsorship for this position. Candidates must be legally authorized to work in the United States at the time of hire and maintain work authorization throughout the employment term**

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

Kelly puts you in charge of your career, with access to cutting edge projects and technologies in
industry leading organizations. Top companies throughout the world have trusted Kelly as a premier
source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm
with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety
and flexibility of working on short term project engagements, or prefer contract-to-hire or direct
hire placement with our clients, apply with Kelly to explore opportunities that suit your specific
professional interests.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.
Posted: 2019-05-27 Expires: 2019-09-05

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Validation Engineer

Kelly Services
Buena, NJ 08310

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