Validation Consultant

Kelly Outsourcing Consulting Group Kelly OCG, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Validation Consultant for an engagement at one of our clients in Gurnee, IL. This role is a full-time, fully benefited position. As a Kelly OCG employee you will be eligible for Medical, Dental, 401K, and a variety of other benefits to choose from. You’ll also be eligible for paid time off, including holiday, vacation, and sick/personal time. All Kelly OCG employees receive annual performance review
Objective:

To draft and execute all necessary documentation and procedures supporting the validation process, perform equipment and process validation, analyze validation data, and author validation reports for the manufacture of a chemical through reaction chemistry.

Responsibilities:


Draft and update documentation and procedures supporting validation processes from scratch, with no existing process validation standards.
Prepare guidelines for conducting risk assessments and implementing risk control measures.
Develop a Validation Master Plan (VMP) outlining the validation approach and responsibilities.
Create Standard Operating Procedures (SOPs) for process validation and equipment qualification (IQ/OQ/PQ).
Establish change control policies for managing changes to processes, equipment, methods, and documents.
Perform validation activities for various equipment types, including risk assessments and equipment qualification (IQ/OQ/PQ).
Conduct process validation activities, including risk assessments and validation protocols (IQ/OQ/PQ).
Execute the validation test plans they have written, carrying out the necessary tests independently.
Analyze validation data to ensure the validation was successful, and establish success criteria related to industry standards concerning chemical contaminants.
Author comprehensive validation reports for equipment and process validation activities.


Qualifications:

Education:


Bachelor’s degree in Life Sciences (e.g., Biology, Chemistry, Biochemistry, etc.), Engineering, or a related field.
Master’s degree preferred.


Experience:


Minimum of 2-4 years of experience in validation activities within a GMP-regulated industry (e.g., pharmaceutical, biotechnology, or medical device).
Experience in drafting and updating validation documents and procedures.
Hands-on experience in equipment qualification (IQ/OQ/PQ) and process validation.
Experience in conducting risk assessments and managing change control processes.


Skills:


Strong understanding of GMP, FDA regulations, and validation principles.
Excellent written and verbal communication skills.
Strong attention to detail and organizational skills.
Proficiency with validation software and tools.
Proven ability to work very independently, as an independent contributor, and execute validation test plans they authored.
Strong problem-solving and analytical skills.
Ability to analyze validation data and establish success criteria related to industry standards on chemical contaminants.
Proficiency with electronic quality management systems (eQMS) and training management systems.


If you, or someone you know would like to be considered for this opportunity, please apply online today to discuss the next steps.



 




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 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.






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