5 days old

Process Validation Engineer II

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

**This role is a full-time, fully benefitted position. As a Kelly employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time.**

**Long Term contract!**

**Salary $80K per year**

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** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (


Posted: 2021-10-11 Expires: 2021-11-11

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Process Validation Engineer II

Kelly Services
Warsaw, IN 46582

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