Position Overview:

• This position serves as a validation representative for laboratory validation activities, including Equipment Qualification and system administration.
  

• In addition, this position is expected to provide technical guidance as A SME with respect to validation/process deviations and change controls as pertains to validation impact.
   

Essential Functions

• Generate, execute and summarize validation documentation for process equipment qualification.
  

• Lead Validation/Qualification/CSV efforts for equipment purchased or modified (FAT, SAT, OQ, PQ).
  

• Coordinate with Quality, technical scientists, and vendors for validation protocols, execution, and final reports
  

• Generate, execute and summarize project plans, conduct and peer review change controls, review validation related exceptions events, as well as provide input to site as a SME.
  

• Contribute to the development and revision of validation concepts, techniques, and standards to ensure compliance with regulatory requirements.
  

• Assist in validation related issue resolutions for all GMP laboratory equipment.
  

• Generate and participate in any change control activities as required.
  

• Participate in any tasks associated with system implementation or upgrades as required.
  

• Lead/support periodic and data integrity reviews.
  

• Participate, support, and drive Continuous Improvement initiatives.
  

• All other duties as assigned
   

Required Education and Experience:

• Bachelor’s Degree in Life Sciences, Physical Science, Computer Science or Engineering field with minimum of 3 years relevant experience, OR
  

• Master’s degree in related Life Sciences, Physical Science, Computer Science or Engineering field required with a minimum of 1 years relevant experience, OR
  

• Doctorate degree in related Life Sciences, Physical Science, Computer Science or Engineering field required with a minimum of 1 years relevant experience.

Required Knowledge/Skills Requirements:

• Proficient in Microsoft Office products (Word, Excel, etc.)
  

• Basic understanding on Minitab or equivalent statistical tool.
  

• Experience with IQ, OQ, and PQ activities
  

• Experience with GMP and GDP activities.
  

• Project management skills

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 & scientific talent and services since 1965. And Engineering & Scientific 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.

As a Kelly Services employee, you will have access to numerous perks, including:

• Exposure to a variety of career opportunities as a result of our expansive network of client companies 
  

• Career guides, information and tools to help you successfully position yourself throughout every stage of your career
  

• Access to more than 3,000 online training courses through our Kelly Learning Center
  

• Weekly pay and service bonus plans
  

• Group-rate insurance options available immediately upon hire*