Associate Validation Specialist

Catalent - Winchester, VA

Full-time - Entry Level

Winchester, VA

10,001+ employees

Chemical Manufacturing

About the position

The Associate Validation Specialist at Catalent is responsible for gathering and interpreting information related to Facility, Utility, and Equipment Validation in accordance with pharmaceutical industry standards. This role involves drafting specifications, protocols, and reports, executing approved protocols, and coordinating activities with various departments. The position plays a crucial role in ensuring compliance with quality standards and supporting customer audits.

Responsibilities

• Draft protocols and reports for Facility, Utility, Production Equipment, Analytical Instruments, and Computerized Systems Validation.
• Develop specification and protocol documents in accordance with site and corporate validation SOPs and guidelines.
• Execute approved protocols and coordinate activities with other departments such as engineering, maintenance, production, and QC.
• Participate in customer audits and respond to audit observations and corrective actions.
• Address Facility, Equipment, Utility, and Computerized Systems Change Controls.

Requirements

• HS Diploma required.
• Bachelor's degree in Life Sciences (e.g., Chemistry, Microbiology) or a minimum of 3 years of pharmaceutical experience in validation, operations, quality control, or quality systems.
• Knowledge of cGMP guidelines and regulations.
• Proficiency in Microsoft Word, PowerPoint, and Excel.
• Working knowledge of TrackWise software.
• Knowledge of SOPs pertaining to validation of facility, utility, equipment, and computerized systems.
• Ability to read and understand system schematics, piping, both mechanical and electrical.
• Ability to complete metric conversions and perform general mathematical calculations.
• Ability to interact and communicate with all departments/customers in person and on teleconferences.

Nice-to-haves

• Experience with validation in a pharmaceutical manufacturing environment.
• Familiarity with regulatory compliance and quality assurance processes.

Benefits

• Tuition Reimbursement
• Generous 401K match
• 152 hours accrued PTO + 8 paid holidays
• Employee Resource Groups focusing on Diversity & Inclusion