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6 days old

Process Engineer

Kelly Services
Bloomington, IN 47407
Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting 12+ year, long term contract opportunity as a Process Engineer for a top fortune 500 company in Bloomington IN.


**Title:** Process Engineer


**Duration:** 12+ months


**Location:** Bloomington IN (85% on site, 15% remote)


**Essential Duties and Responsibilities:**


+ Support Engineer for Start-up, commissioning, and qualification of a new aseptic vial filling line including the following equipment for the line (open RABS) + SCADA system:

+ Washer

+ Depyrogenation Tunnel

+ Filler

+ Capper (2)

+ Gauntlet glove Testing system

+ Engineering support for demolition and construction (removal of old line, install new, designperformed by others)


+ Support start-up, commissioning, and qualification of potential facility modifications to HVAC systems and critical utilities

+ Management of equipment OEMs, timeline, task, and closure of open issues/deviations

+ Review detailed design and testing documentation provided by OEM

+ Write Process SOPs, Forms, Job Aids, etc. for new equipment

+ Planning and Coordination of activities between client resources, OEM resources, and Design and Construction Management Firm, and OEM validation services, including participation in of FAT, SAT, IQ/OQ

+ Knowledge experience with computer system validation (21CFR Part 11) as it relates to fillingprocess equipment is preferred (integrated process equipment as opposed to enterprisesystems)

+ Develops into and serves as temporary subject matter expert (SME) for new equipment andsupports internal team members with process development and PQ activities

+ Perform gap assessments on OEM qualifications, author client IQ/OQ documentation andsummaries; Equipment History Form, System and Component criticality assessments, New Instrument Calibration Forms, Electronic System Assessment Forms, PM generation, EHS Equipment Checklist, & Assessment and set up of spare parts inventory

+ Identification, Specification and procurement of any necessary tooling and equipment tooperationalize production lines

+ Training of cross functional groups and development of supporting entry levelengineers into SME


**Qualifications:**


+ 5+ years of experience

+ Experience working in pharmaceutical, medica device, food/beverage or other highly regulated industry preferred

+ Experience with Aseptic Filling startups preferred


**Education / Experience:**


+ Bachelors degree


**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please contact Michelle Niemira ( micn083@kellyservices.com ) for immediate consideration.


**Why Kelly?**


+ As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ 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** **** **?**


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: 2021-09-10 Expires: 2021-10-11

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Process Engineer

Kelly Services
Bloomington, IN 47407

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