Senior Engineer I, Validation

Senior Engineer I, Validation

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. 

The Validation group has oversight of the validation program, including commissioning and qualification, cleaning validation, and computer system validation as well as the activities required to maintain systems in a qualified and/or validated state, including change control, requalification, and system reviews.

This is a full-time on-site salaried position, Monday - Friday 8:00am - 5:00pm

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:  

• Trains, motivates, and leads Validation personnel with oversight from management
• Assists with maintaining Commissioning, Qualification, and Validation Master Plans and supporting procedures in alignment with industry standards and corporate policies
• Provides guidance and oversight for commissioning, qualification, and validation of systems and processes
• Drafts, reviews, and executes plans, protocols, and reports related to commissioning, qualification, and validation of systems and processes. This includes associated protocol events.
• Maintains systems and processes in the qualified and/or validated state, including performing and reviewing requalification’s and periodic reviews
• Reviews change controls to assess impact to commissioned, qualified, and validated systems and processes
• Serves as a quality contact and subject matter expert (SME) for simple qualified and/or validated systems and processes
• Implements improvements to established systems, processes, procedures, etc. to support quality management systems with oversight from management
• Other duties as assigned

The Candidate:  

• Must have Doctorate Degree in a STEM discipline and 0-3 years related experience OR
• Master's degree in a STEM discipline with minimum of 4 years related experience OR
• Bachelor's degree in a STEM discipline with minimum of 6 years related experience OR
• Associates degree in a STEM discipline with minimum of 10 years related experience
• Prior work experience with quality management software such as TrackWise or ComplianceWire is preferred
• Occasional stooping, kneeling, crouching, bending, carrying, grasping is required
• Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds is required
• Must comply with EHS responsibilities for the position.

Why you should join Catalent:

• 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 and Paid Time Off accrual 
• Medical, dental and vision benefits effective day one of employment 
• Tuition Reimbursement

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. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.