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19 days old

Validation Engineer - Labeling - Medical Device Manufacturing

Kelly Services
San Diego, CA 92108
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a temporary opportunity to work as a **Validation Engineer** ** Labeling - Medical Device Manufacturing** at a prestigious Fortune 500 company working in **San Diego, CA.**



This is a 12-month contract position at 40 hours per week.



**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 ( keig126@kellyservices.com ) however your resume must be received via the submit now button included within.





**Duties:**




+ The Validation Engineer is responsible for the execution and management of validation activities for process, cleaning, equipment, computer software or facilities on site.

+ The engineer prepares and executes validation/qualification and re-qualification activities for new and modified process, cleaning, equipment, computer software or facilities so that the qualification status of site is always maintained.

+ The engineer also assists external qualification personnel with the execution of major project qualification activities which require the use of temporary external resources.

+ Ensure all company and Site Validation policies and procedures are adhered to.

+ Ensure all work carried out and equipment installed is safe, effective and in compliance with the appropriate industry standards.

+ Ensure all work undertaken is reflected accurately in up to date Validation / project information files.

+ Lead installation and all qualification activities for Purified Water (PW), Clean In Place (CIP) and equipment cleaning systems.

+ Lead all validation activities for new and/or changes to labels applied to all Manufacturing products to include expertise with HF RFID systems and tags. These activities extend to adhesive and ribbon/ink changes as well.

+ Lead/support the development of process, cleaning, equipment, computer software or facilities protocols and ensures they are in line with Validation policies and guidance documents (Liaising with equipment manufacturers, internal and external project personnel to ensure successful qualification execution).

+ Seek and retain approval for qualification protocols from site User groups (who approve documents from a user group operations perspective) and Quality (who approve documents from a regulatory compliance standpoint).

+ Lead the execution of qualification protocols on process, cleaning, equipment, computer software or facilities as necessary.

+ Ensure the maintenance of a qualification document listing for all qualified equipment on site.

+ Ensure all qualification documentation is always maintained up to date.

+ Provide expert guidance for the resolution of technical issues arising during the execution of qualification activities.

+ Perform any other activities as directed by the Validation Manager.





**Required Skills and Abilities:**



Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) required



Technical expertise in biotech unit operations, ability to handle multiple projects at one time



Strong technical expertise all aspects of PW, CIP and equipment cleaning systems and processes



Strong expertise in leading validation activities for labeling and HF RFID systems as well as label ribbon/ink label validation activities



Working knowledge of processes in fermentation, purification and/or formulation required



Strong leadership, organizational planning, and project management skills



Excellent interpersonal effectiveness and communication skills (written and oral)



Ability to work with a cross functional team to achieve expected results



Direct hands on experience with validation of process, cleaning, equipment, computer software or facilities




+ Proficient in MS Word, Excel, and Project





**Occupational Demands:**




+ Ability to lift 20-30 lbs. and stand for an extended period of time.





**Education:**




+ Bachelor's Degree in Engineering or Science discipline, advanced degree is a plus.

+ 4 years of relevant validation experience can be substituted in lieu of Bachelors Degree



**Years of Experience:**




+ Minimum 5+ years of relevant validation experience in regulated industry with a Bachelors Degree in Engineering or Science discipline; or

+ High School Diploma with 9+ years of relevant validation experience






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



Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.




**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/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. 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 is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2021-01-01 Expires: 2021-02-01

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Validation Engineer - Labeling - Medical Device Manufacturing

Kelly Services
San Diego, CA 92108

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