Manager - Validation

Manager, Validation

The Manager, Validation will have the opportunity to establish and further the Catalent Cell Therapy Validation department with collaboration from key stakeholders while playing a prominent role in executing site validation strategy and activities. This role supports the Catalent Princeton, NJ facility for both clinical and commercial operations. The Manager, Validation is responsible for directing all validation activities for this site, including the qualification of manufacturing equipment/utilities, cleaning processes, manufacturing processes, computer/software, and aseptic processes.

This is a full-time, salaried position. Monday-Friday, 1st shift.

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:

• Development and maintenance of the Catalent Cell Therapy Validation Program including strategy development (policies and guidance) as well as creating detailed processes and procedures (SOPs)
• Collaboration with key stakeholders to ensure all aspects of validation (CQV and CSV) are included in the Catalent Cell Therapy Validation Program
• Own the site’s Validation Master Plan and Validation Project Plan and Budgetary input for organization, including preparation, maintenance, and re-forecasting.
• Providing a growing team structure with guidance and support during ongoing organizational growth. Lead by example exhibiting Catalent Cell Therapy values and ensuring teams have the necessary day to day direction and training to execute required activities (qualifications/validation protocols, etc...)
• Investigation of exceptional conditions during the execution of protocols as well as other atypical events, deviations, and non-conformances as required.
• Assure GxP operations are executed in compliance with applicable guidelines and regulations through quality risk management, risk assessment, and auditing functions.
• Works closely with management from Manufacturing, QA/QC and Facilities in determining the approach to the execution of validation activities, as applicable.
• Serves as Validation lead when interacting with clients and/or regulatory bodies; Leads the regulatory defense of validation protocols and summary reports during audits and internal audits.
• Direct continuous improvement initiatives for the validation of cleaning, aseptic, and manufacturing processes
• Other duties as assigned.

The Candidate:

• Bachelor degree in Engineering or Science field AND
• 6 or more years of experience in biopharma Validation/Quality role AND
• 3 or more years in a supervisory/management role 
• Experience with designing and leading a successful Performance Process Qualification (PPQ) campaign is highly desirable
• Experience with CSV activities supporting clinical and commercial operations
• Experience in designing and leading Aseptic Process Simulations is highly desirable

Catalent Benefits:

• Defined career path and annual performance review and feedback process 
• Diverse, inclusive culture 
• Potential for career growth on an expanding team within an organization dedicated to

preserving and bettering lives 

• 152 hours of paid time off annually  8 paid holidays 
• Competitive salary with yearly bonus potential 
• Community engagement and green initiatives 
• Generous 401K match
• Medical, dental and vision benefits effective day one of employment 
• Tuition reimbursement 

Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

• Leads with Integrity and Respect
• Delivers Results
• Demonstrates Business Acumen
• Fosters Collaboration and Teamwork
• Champions Change
• Engages and Inspires
• Coaches and Develops

Catalent offers rewarding opportunities to further your career!  Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. 

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

Salary : $114,000 - $145,000