Kelly Services Validation Engineer in Brooklyn Park, Minnesota

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a 3-4 month contract opportunity to work as a Validation Engineer in a prestigious Fortune 500® Pharmaceutical company located in Brooklyn Park, MN.

Summary:

  • This position will be responsible for assisting the validation department in the validation of standalone manufacturing equipment

Accountabilities:

  • Assist in performing risk assessments, FMEA and document results.

  • Using requirements and design documentation, develop Installation and Operational IOQ protocols and Trace Matrix.

  • Execute qualification protocols, document protocol deviations and generate qualification protocol summary reports

  • Assemble and maintain qualification protocol test records and associated data.

  • Performs other duties as assigned.

  • Proficient in Microsoft Word and Excel, and other desktop computing software.

  • May occasionally work in a clean room environment and wear special garments and personal protective equipment

  • e.g. hard hats, safety shoes, safety glasses, ear plugs due to safety requirements in specific areas.

Education, Experience, Knowledge & Skills:

  • Minimum of a Bachelor of Science in Sciences/Engineering other degrees accepted

  • 2-3 years validation experience in GMP Pharmaceutical manufacturing environment.

  • Medical device experience may also be considered.

  • *An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

  • Prepare various validation documents including traceability matrices, qualification protocols, and summary reports.

  • Perform qualification protocol test execution, and manage protocol deviations investigation and corrective action activities.

  • Previous experience performing Temperature Mapping of Fridges/Cold Rooms/Incubators.

  • Experience using the Kaye Validator/Valprobes for temperature mapping is a plus.

  • Working knowledge of cGMP guidelines, FDA 21 CFR Part 210/211, ICH guidelines and other international regulatory requirements.

  • Strong organizational skills, with the ability to handle multiple tasks and strong attention to detail.

  • Good oral and written communication skills, with the ability to interact appropriately with all levels of management and staff, client and regulatory personnel, and to work as part

Important information

This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “submit now” button below to submit your resumes. If you have questions about the position, you may contact the recruiter recruiting for this position ( trab974@kellyservices.com ) however your resume must be received via the “submit now” button included within.

By working with Kelly in this role, you would be eligible for:

  • A competitive hourly pay rate with weekly checks

  • Access to newly expanded Medical Plan options

  • Online continuing education via the Kelly Learning Center

  • Several employee discounts

  • And more!

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 2016 was $5.3 billion. Visit kellyservices.com 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm