1+ months

Validation Engineer

Kelly Services
Arlington Heights, IL 60004

Kelly Engineering is currently recruiting for a Validation Engineer. This position will support the professional members of the team responsible for engineering and manufacturing; provides processing support to manufacturing for products, assemblies, blow, fill, seal processes, packaging processes, and supporting utilities; performs engineering duties to set up engineering tests, studies, and validations; assists the engineers with tests and evaluations; recommends improvements to manufacturing procedures through submittal of EO; develops and writes procedures; performs other related duties as required.

Responsibilities Include:

*Develop, set up, write, and run Validations

*Evaluate the processes and equipment utilized to manufacture products

*Provides technical expertise to the manufacturing floor in the areas of root cause analysis, troubleshooting, process problem solving, risk analysis, statistical analysis, and process improvements

*Researches and solves related process and material problems as necessary

*Develops product specifications, process steps, diagrams, protocols, procedures, forms, Engineering Orders, drawings, and other documents related to manufacturing processes

*Develops cost reduction programs to achieve corporate goals

*Prepares/collects data to ensure BOM accuracy

*Provides sample documentation, reviews results, and issue specifications

*Set up test studies as needed and conducts the evaluation of products produced

*Ensures products are produced to specifications; writes operating procedure changes to improve the production process as necessary

**Qualified candidates will have the following education/experience to be considered:**

*Candidate will have graduated from an accredited college with a Bachelor Degree in Engineering (Mechanical), Science, Quality Systems, and/or Industrial Manufacturing Technology.

***Minimum 5 years of Process/Equipment Validation experience in a medical manufacturing industry.**

***GMP and related requirements for sterile blow, fill, seal operation and assembly of critical medical components and devices**

***Knowledgeable of FDA, USP, ISO, EU, OSHA, EPA regulations**

***Experience developing and executing IQ/OQ/PQ documents for equipment, cleaning and test method validations**

*Understanding of the principles and practices of processing equipment

*Working knowledge of sterile processing equipment operation

*Knowledge of plastic materials, additives, films, and dyes

*Knowledge of packaging and labeling operations

*Knowledge of Quality and Manufacturing Systems, CAPA, NR, SAP, SPC, RA

*Knowledge of manufacturing and packaging procedures

*Understanding of Lab Testing Practices and Calibration Requirements

*Understanding of principles of manufacturing processes to properly setup an efficient operation of production systems

*Office skills including computer functions/applications MS Word, Excel, Projects, Access, Power Point, Outlook, and Visio

*Basic understanding of CAD

*Understanding of research methods including technical writing skill to develop reports

**NOTE: This company does not offer H-1B or any other work authorization visa sponsorship for this position. Candidates must be legally authorized to work in the United States at the time of hire and maintain work authorization throughout the employment term**

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

Kelly puts you in charge of your career, with access to cutting edge projects and technologies in
industry leading organizations. Top companies throughout the world have trusted Kelly as a premier
source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm
with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety
and flexibility of working on short term project engagements, or prefer contract-to-hire or direct
hire placement with our clients, apply with Kelly to explore opportunities that suit your specific
professional interests.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 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: 2019-06-24 Expires: 2019-09-16

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Validation Engineer

Kelly Services
Arlington Heights, IL 60004

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