27 days old

Validation Engineer (Medical Device)

Kelly Services
Rochester, NY 14651
Validation Engineer (Medical Device)

Rochester, NY

24 months W2 contract


**What will you do?**

Validation is the process of establishing documented evidence that a procedure, process, equipment or other activity will consistently perform as intended throughout its life cycle. As a Validation Engineer II, you will be responsible to interact with several departments to create and execute validation testing in support of individual equipment, systems, environments, cleaning efficiency, or processes required for pharmaceutical packaging operations at the site.


+ Within Laboratory Plastics, the individual will be responsible for the preparation and execution of validation protocols (VP, IQ, OQ, PQ, and others), along with their associated summary reports, in service of items including:

+ Packaging and automation equipment

+ Metrology equipment

+ Computer control systems, including a Building Automation System (BAS)

+ Molding machines and molds, with associated secondary equipment

+ Other specialized areas as project are requested

+ Conduct all work according to governing SOPs and cGMPs (current Good Manufacturing Practices).

+ Prepare detailed reports or design statements knowledge obtained from learning about new equipment coming to the site.

+ Coordinate Validation Projects with other departments and ensure project timelines

+ Demonstrates and promotes the company vision of the 4 Is: Integrity, Intensity, Innovation and Involvement

+ Author SOPs related to validation department activities

+ Conducts all activities in a safe and efficient manner

+ Other duties may be assigned to meet business needs

**How will you get there?**

+ Bachelor of Science degree required, with an Engineering or Science discipline preferred.

+ 1-2 years of validation experience (or internships) in a regulated industry or equivalent validation experience including food or pharmaceutical packaging

+ PC literacy including the ability to generate complex documents in both Microsoft Excel and Microsoft Word

+ Able to independently drive projects through clear communications, schedules, and team meetings

+ Have strong interpersonal and analytical skills

+ Able to multitask and respond to shifting priorities

+ Must have good communication skills, both written and verbal

+ Be results oriented

+ Must have mechanical and process equipment aptitude

+ Must be able to lift 35 pounds

**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/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 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.
Posted: 2021-05-24 Expires: 2021-06-24

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Validation Engineer (Medical Device)

Kelly Services
Rochester, NY 14651

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