Process Validation Manager

Disability Solutions - Bloomington, IN

Full-time - Mid Level

Bloomington, IN

Administrative and Support Services

About the position

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. The Validation strategy is to manage projects relating to biopharmaceutical manufacturing equipment, critical computer systems, manufacturing processes, and documentation to ensure the validation deliverables meet the quality standards and requirements of company policies and FDA regulations. The Process Validation Manager's responsibilities include managing multiple projects to provide documented validation of manufacturing processes, establishing philosophy, structure, and scope in compliance with regulatory requirements through Validation Master Plans, policy and standard operating procedures. This role involves managing the activities of direct reports to accomplish the scope of work of the validation department, managing protocol and report development, execution, and approval associated with process validation, reviewing and approving documentation, evaluating and determining required validation testing, and validation services including contract review and approval, and overseeing the implementation of validation requirements. This is a full-time role working days, Monday - Friday, and requires flexibility to meet business needs. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The role also involves developing qualification strategies and documents for novel processes, training new team members, and providing technical oversight of work performed by Technicians, Associate Engineers, and/or Engineers. The Process Validation Manager will ensure employees' career development, take responsibility for direct reports' performance by setting clear goals and expectations, coaching, supporting, and tracking progress against the goals, ensuring constructive feedback, and addressing performance-related concerns and issues promptly. Additionally, the role includes formal client communications, leading client meetings, reviewing change controls for process impact, supervising validation personnel, and implementing improvements to established systems, processes, and procedures to support quality management systems with oversight from management. Other duties may be assigned as necessary.

Responsibilities

• Manage multiple projects to provide documented validation of manufacturing processes.
• Establish philosophy, structure, and scope in compliance with regulatory requirements through Validation Master Plans, policy, and standard operating procedures.
• Manage the activities of direct reports to accomplish the scope of work of the validation department.
• Manage protocol and report development, execution, and approval associated with process validation.
• Review and approve documentation related to validation processes.
• Evaluate and determine required validation testing and validation services including contract review and approval.
• Oversee the implementation of validation requirements.
• Develop qualification strategies and documents for novel processes.
• Train new team members and provide technical oversight of work performed by Technicians, Associate Engineers, and/or Engineers.
• Ensure employees' career development and performance management.
• Lead formal client communications and meetings regarding process validation topics.
• Review change controls for process impact and supervise validation personnel.

Requirements

• Bachelor's Degree required; Master's Degree preferred.
• 3-5 years of relevant leadership experience.
• 5 years of GMP or other regulated industry experience required.
• Strong understanding of guidance documents from FDA, EMA, PDA, ISPE, and other industry organizations.
• Understanding of validation technical disciplines, including equipment, cleaning, computer system validation, and process validation.
• Ability to read and understand English-written job instructions and safety requirements.

Benefits

• Competitive medical benefits and 401K
• 152 hours of PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes