VALIDATION MANAGER

POSITION SUMMARY:

The Validation Manager oversees all validation activities and provides management support to the site regarding validation activities. This position reports to the Director of Quality.

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:

• Oversee all validation activities including equipment, computer systems, process, facilities, utilities, and cleaning qualifications
• Ensure that the validation activities comply with the regulatory requirements.
• Conduct continuous improvement of validation processes
• Make decisions on validation strategy
• Review and approve validation documents
• Support deviation investigation related to validation activities
• Provide technical information to internal and external clients
• Provide updates to senior leadership and report KPI's
• Other duties as assigned.

THE CANDIDATE:

• Bachelors of Science degree in Scient or Engineering.
• Extensive understanding of pharmaceutical validation requirements.
• Strong leadership and people management skills.
• Ability to support direct reports by providing guidance and removing obstacles.
• Understanding of process improvement principles.
• Ability to work with Quality Assurance and Operations to maintain compliance.
• Experience writing and executing technical documents.
• Excellent oral and written communication skills.
• Good organizational skills relating to management of associates daily activities.
• Problem solving and decision-making skills requiredAbility to work effectively under pressure to meet deadlines.
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds. Be accessible to laboratory and pilot plant area(s) and office staff and to use required office equipment.

WHY YOU SHOULD JOIN CATALENT:

• Day 1 Medical, 401K and Tuition Reimbursement benefits
• 19 days of PTO + 8 paid holidays
• Awesome employee activities: Monthly Birthday Celebrations, Pastry Breakfast, Close of Quarter Pizza appreciation, Bowling events, 5K walk/runs and several other company sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment;
• Environmentally friendly
• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Dynamic, fast-paced work environment
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Competitive salary with quarterly bonus potential
• Community engagement and green initiatives
• Medical, dental and vision benefits effective day one of employment

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.

Catalent is a global leader in providing integrated services, superior drug delivery technologies and manufacturing solutions to help life science innovators develop and launch successful pharmaceuticals, biologics and consumer health products. We have built an advanced range of technologies and capabilities and are dedicated to enabling a better and faster customer journey from product development directly to patient. At Catalent, we share a common goal, to put patients first and help people around the world live better and healthier lives.