1+ months

Process Validation Engineer

Kelly Services
Warsaw, IN 46582
**Process Validation Engineer II**

**Kelly Outsourcing & Consulting Group (KellyOCG), a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Process Validation Engineer for a Project engagement at one of our Global clients in Warsaw, IN. This role is a full-time, fully benefitted position. As a KellyOCG employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. Youll also be eligible for paid time off, including holiday, vacation and sick/personal time. All KellyOCG employees receive annual performance reviews.**

**$40 per hour**

**Job Description**

This role provides engineering support for manufacturing operations based within the Final Clean & Packaging value stream. The role requires technical ownership to be taken for cleaning, passivation, packaging, and sterilization processes, as well as products, and equipment. Maintaining a focus on key business drivers, which include EH&S, Quality, Supply and Cost are an imperative of this role.

As process owner, this role will involve collaborating with a number of functional groups to deliver value stream projects, such as NPI and Manufacturing Engineering, as well as with suppliers and other sites within the engineering, science, and technology network that run similar processes. This position will foster opportunities to demonstrate strong leadership, work ethic, and Credo-based behaviors!

**Principle Responsibilities**


+ Support attainment of key business metrics through the provision of engineering support for cleaning, passivation, packaging, and sterilization processes.

+ Elimination of safety and quality risks in the process through implementation of robust engineering solutions.

+ Develop stable and capable manufacturing processes using process capability tools.


+ Actively promote a safety culture.

+ Provide guidance to contractors and vendors working on site to ensure full compliance with site safety requirements.

+ Ensure production equipment meets all relevant national and J&J Health, Safety and Environment requirements through completion of required assessments and documentation.


+ Proficient in validation requirements for new manufacturing materials and process changes.

+ Ensure timely execution of quality actions related to scrap, holds, audit, NCR, and CAPA.

+ Ensure all process development and validation carried out and maintained in accordance with the Quality management system.


+ Support daily operations through attendance at pulse walks and the timely closure of actions.

+ Project Management - provide timely and accurate reporting on project activities ensuring projects are delivered to agreed timelines.

+ Root Cause Analysis and implementation of robust solutions to supply and quality issues as they arise through tools such as A3 and Six Sigma.


+ Reduce costs by implementing scrap, reprocessing, and consumable projects.

+ Identify and lead cost and technical improvements under the departments continuous improvement program.



+ Bachelors Degree or equivalent in a relevant Engineering / Science field, with 2+ years proven experience.

+ Experience in Validation of equipment and implementation of automated processing solutions.

+ Experience in regulated industry, FDA, ISO, etc.

+ Demonstrated ability to lead projects to completion, on time and within budget

+ Demonstrated leadership skills and the ability to make effective decisions

+ Demonstrated ability to prioritize multiple assignments or projects with sound analytical, troubleshooting, and problem-solving skills.

+ Demonstrated Continuous Process Improvement approach


+ Experience with troubleshooting, operating, design, installation and validation of clean and pack equipment in a regulated environment.

+ Certification in Six Sigma, Statistical Engineering, Lean Six Sigma

+ Demonstrated ability for Excellent interpersonal skills (written and oral)

+ Experience in Automated Process Control and Systems, including Allen Bradly, Siemens, or equivalent.

+ PLC Programming.

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

The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ) is one focus within the full array of Kelly Services workforce solutions.

Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.

The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit 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. (
Posted: 2021-10-27 Expires: 2021-12-27

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Process Validation Engineer

Kelly Services
Warsaw, IN 46582

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