Kelly Services is actively recruiting for a Sr. Validation Engineer for a Direct Hire opportunity in Morton Grove, IL.

　　POSITION SUMMARY:

　　This position is responsible for managing the Cleaning and sanitization Program for the site. Position requires knowledge of Cleaning and Sanitization Validation for OTC and cosmetic's. The position requires to be the Subject Matter Expert in the field of Cleaning and sanitization program and validation. Be able to support the facility and attest to cleaning during internal and external audits. Position requires ability to problem solve, work on cross functional teams, mentor staff, work with cross functional teams from batch processing, packaging and micro laboratory and work independently.

　　Responsibility

　　Lead the Cleaning, sanitization & Validation Program:

　　Plans, implements a robust cleaning and sanitization program by authoring and leading the sanitization Validation Program for all products and product contact equipment.

　　Leads the execution of the cleaning and sanitization validations by authoring protocols, hands on execution of the protocols and authoring the final report

　　Ensures that deliverables are carried out in a timely and compliant manner.

　　Author or update SOP’s to support the cleaning the sanitization program.

　　Lead the training for the processing and packaging personal on the execution of the cleaning and sanitation SOP’s

　　Supports the Sr. Quality Manager during external and regulatory audits.

　　Leads the activities related to investigations for Micro OOS’s, initiates and follows-up on the implementation of corrective actions

　　Subject Matter Expert in the field of Cleaning and santatization program & Validations

　　Leads the personal Hygine program to ensure proper PPE’s for the site are appropriate for each area of the facility and ensuring cGMP’s are followed and adhered to.

　　Support the Cleaning & Sanatization processing and packaging personal

　　Reviews performances of Cleaning and Sanitization program in regard to the achievement of goals, objectives and key result areas.

　　Designs, develops and evaluates plans for projects/studies/investigations/reviews.

　　Completely responsible for planning and execution of all tasks needed to the execution of the cleaning validations.

　　Seeks advice on planning from management when there are priority conflicts.

　　Able to make independent contributions to the development of new technologies, developing and revising methods and procedures to assure compliance with applicable regulations; carries out technical and administrative duties as assigned.

　　Trains on new and existing procedures, techniques and governmental regulations as directed by management.

　　EDUCATION AND EXPERIENCE:

　　BS degree in Biology, Chemistry, Microbiology, Biochemistry or relevant science discipline – 8 years of relevant Quality experience preferably in the pharmaceutical industry.

　　MS degree in Biology, Chemistry, Microbiology, Biochemistry or relevant science discipline – 6 years of relevant Quality experience preferably in the /pharmaceutical industry.

　　Strong background in Cleaning and sanitization progam and validations

　　Mentor/trains in routine procedures demonstrating expertise.

　　TECHNICAL SKILLS REQUIREMENTS:

　　Extensive practical and solid theoretical knowledge of applicable compliance guidelines of the FDA or other regulatory bodies; and relevant Client SOPs.

　　In addition to high technical competence, understands and can articulate the scientific/regulatory principles that underlie practices and guide future projects/studies/reviews development. Continues to expand breadth of technical expertise.

　　Ability to interpret and document results according to standard operating procedures using all Quality Systems guidelines.

　　Demonstrated ability to independently develop, document and troubleshoot methods of moderate complexity.

　　Ability to lead teams from work cross functional areas

　　Ability to provide equipment and procedure training and to share technical expertise with less experienced colleagues to solve problems.

　　Can independently design and carry out a series of studies/reviews to solve a problem or evaluate a process/procedure. Solutions may involve the development of new techniques and procedures. Uses literature and colleagues as resources in order to solve problems.

　　If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.

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　　As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

　　Why Kelly ® Science & Clinical?

　　Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

　　About Kelly

　　Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

　　Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center.Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

　　Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.