Computer System Validator

3 weeks ago


Harmans, Maryland, United States Catalent Inc Full time

About Catalent:
Catalent Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. We are dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, we support the acceleration of development programs and the launch of more than a hundred new products every year.

Job Description:
We are seeking a highly motivated and experienced Senior Validation Engineer to join our team. As a member of our team, you will actively contribute to the delivery of our services and products to our customers and their patients. Your primary responsibilities will include:

  • Author and review validation protocols for computer systems, including IQ, OQ, and PQ protocols
  • Develop and/or review validation requirements and design deliverables
  • Coordinate multiple projects and document activities via protocols and summary reports
  • Establish validation strategies and policies, as needed, including reviewing facilities changes and providing input on re-validation
  • Assess risks involved in processing steps related to equipment, facility/utility, and computer systems validation

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
- Knowledge of FDA guidelines and Global cGMPs relevant to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE GAMP guidelines
- In-depth knowledge of the validation lifecycle to ensure compliance to 21 CFR Part 11, Eudralex Annex 11, GxP, and applicable FDA/EMA Guidance

Salary:
$100,000 - $135,000 per year. This compensation package also includes medical, dental, and vision benefits effective day one of employment, a generous 401K match, company match on donations to organizations, tuition reimbursement, and a comprehensive set of employee benefits.


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