Validation Engineer II

Catalent • Greenville, NC

435d

About The Position

The Validation Engineer II at Catalent plays a crucial role in supporting operations, clients, and various departments to ensure that processes, equipment, systems, and facilities are qualified and maintained in a validated state. This position involves authoring and reviewing validation protocols, performing validation testing, and analyzing data to ensure compliance with industry standards. The role is integral to maintaining the quality and safety of pharmaceutical products, contributing to the company's mission of improving patient health.

Requirements

• Bachelor's degree in Technical or Life Sciences discipline with at least 2 years of experience in the pharmaceutical industry, or an Associate degree in Technical or Life Sciences discipline with at least 4 years of experience in the pharmaceutical industry.
• 1+ years of validation experience is preferred.
• Some exposure to hazardous chemicals and other active chemical ingredients is required.
• Ability to handle and manipulate objects using hands and arms is necessary.
• Must be able to complete a medical evaluation with satisfactory results to wear a respirator.

Nice To Haves

• Experience in a fast-paced pharmaceutical manufacturing environment.
• Knowledge of regulatory requirements related to validation in the pharmaceutical industry.

Responsibilities

• Author and review process validation protocols and validation summary reports for Process, Cleaning, Computer and Engineering (Equipment, Facilities, Utilities) Validation.
• Perform validation testing and analyze data for validation documentation to determine acceptability, identify deviations, and make appropriate notifications.
• Act as the Client Validation representative for product validations, attending meetings and supporting client questions and requests associated with product validation and Continued Process Verification.
• Create product monitoring plan protocols, collect and statistically analyze batch data, and compose CPV documentation such as product dashboards and reports.
• Conduct periodic review, mapping, remapping, and revalidation for Equipment and Utilities.
• Utilize a validation life cycle approach and follow the site master validation plan.
• Perform all other duties as assigned.

Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement savings plan with company match.
• 152 hours of PTO plus 8 paid holidays.
• Opportunities to work on Continuous Improvement Processes.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Associate degree
• Number of Employees: 10,001+ employees