Senior Validation Specialist

3 days ago


Fishers, Indiana, United States INCOG BioPharma Services Full time

Job Description:


We are seeking a highly skilled Sterile Injectables Validation Expert to join our team at INCOG BioPharma Services. The ideal candidate will possess a deep understanding of validation requirements for sterile injectables manufacturing facilities.


Key Responsibilities:



  • Perform qualification activities on utilities, equipment, and laboratory systems, including clean utilities, autoclave, washer, filler, laboratory instruments, and controlled temperature units.
  • Interact with clients to provide validation support for customer product launches, new equipment qualifications, and capital expansion projects.
  • Support and provide validation oversight for facility changes, re-validation, and re-qualification of equipment.
  • Assess risks involved in processing steps related to equipment and develop validation requirements and design deliverables.
  • Conduct validation qualifications in accordance with applicable protocols and identify associated protocol excursions.
  • Identify industry trends in validation and propose program modifications to align with current requirements.

Requirements:



  • Bachelor's degree or higher in a STEM discipline.
  • 5-8 years of experience in validation or a related discipline.
  • 4+ years of GMP experience required or other regulated industry experience.
  • Physical capability to work onsite.

About INCOG BioPharma Services:


INCOG BioPharma Services is a world-class CDMO for parenteral injectable drugs. Our culture and priorities are centered around building long-term value for our customers, with a focus on technical excellence and a collaborative team-centered approach to doing business.


Equal Opportunity Employer:


INCOG BioPharma Services is an equal opportunity employer and prohibits discrimination and harassment of any kind. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, age, physical disability, sexual orientation, family or parental status, or any other status protected by laws or regulations in the locations where we operate.



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