Senior Validation Engineering Specialist

4 weeks ago


Harmans, Maryland, United States Catalent Inc Full time

Catalent Inc. is a global leader in the pharmaceutical industry, providing innovative solutions for the development and manufacturing of new treatments. As a Senior Validation Engineering Specialist, you will play a key role in ensuring the quality and integrity of our computer systems and equipment.

Overview

We are seeking an experienced Senior Engineer to join our team at Catalent's Harmans, MD facility. The successful candidate will be responsible for coordinating validation projects related to manufacturing equipment, critical computer systems, and laboratory documentation. This is a full-time, salaried position with a competitive salary range of $85,000-$120,000 plus shift differential and annual bonus, when eligible.

Responsibilities
  • Author and review validation protocols for Computer Systems, including IQ, OQ, and PQ protocols related to manufacturing equipment.
  • Develop and/or review validation requirements and design deliverables.
  • Review and provide guidance on deviations/defects during IOQ/PQ executions.
  • Lead all aspects of validation efforts relating to computer systems.
Requirements
  • Bachelor's degree in a Science or Engineering field required with a minimum of five (5) years of direct CSV engineering experience.
  • Able to work in a team setting and independently under minimum supervision.
  • Experience with CSV Commissioning and Qualification activities in a regulated industry.
Why Choose Catalent?

We offer a dynamic, fast-paced work environment, generous benefits, and opportunities for career growth. Our diverse, inclusive culture prioritizes continually improving processes to remain innovative. Join us in making a difference and advancing new medicines from early development to clinical trials and to the market.



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