20 days old

Process Engineer

Kelly Services
Bloomington, IN 47407
**Process Engineer**

**Location: Bloomington IN**

**This is a 3-month Contract opportunity!**

**Hours per week: 40+**

**Payrate: $45-50/hr.**


The Technical Services Associate II (Risk Management) is responsible for risk management activities associated with non-conformances, complaints, equipment validation, qualification and change control activities at the BPS site. This position interacts with clients, regulatory agencies and cross-functional teams (Engineering, Technical Services, Manufacturing, etc.) to ensure timely approval of all associated documents. This position reports to the Technical Services Validation Sr. Manager.

**Essential Duties and Responsibilities**

+ Provide guidance and technical expertise of regulatory and Baxter requirements in Risk Management strategies and processes.

+ Assess risk associated with non-conformances complaints, audits, change control etc. and update the site process FMEA with new risks as needed.

+ Approve risk forms submitted with newly identified risk submitted via non-conformance investigations, complaints, audits, change control etc.

+ Author and/or approve applicable risk assessment documents for equipment and manufacturing process related changes.

+ Author and/or approve applicable deviation reports for product and process related deviations.

+ Help lead Risk Management activities for sustaining Engineering/Manufacturing projects

+ Subject matter expert (SME) and key participant in compliance audits, inquiries and SOPs.

+ Provide SME input to risk remediation activities.

+ Support risk assessment of new processes to be validated.

+ Uses statistical tools to analyze data.

+ Performs annual reviews of all process FMEAs.

+ Participates in regulatory inspections.

**Job Requirements (Education, Experience and Qualifications):**

+ Bachelors degree required, preferably in a science or engineering related field

+ Minimum of 2 years pharmaceutical industry experience in parenteral manufacturing

+ American Society of Quality (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification a plus.

+ Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, Pilgrim, Trackwise, etc.)

**Why Kelly?**

As a Kelly employee, youll have access to world-class perks, including:

+ Kelly-sponsored Affordable Care Act health care coverage available to eligible employees

+ *Group insurance options

+ Service bonus plan

+ Holiday pay plan

+ Weekly electronic pay options

+ Online training campus that provides more than 3,000 free courses to help improve and develop skills

+ Exclusive online employee community

+ Employee assistance program available at no cost

+ Corporate discounts

+ Transportation Spending Accounts

*Offered and administered by Leslie & Associates. These plans are not sponsored by Kelly Services.

**Apply Today!**

**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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Process Engineer

Kelly Services
Bloomington, IN 47407

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