Senior Validation Engineer

Position Summary:

Catalent Pharma Solutions in Somerset, NJ is hiring a Senior Validation Engineer for the Engineering group. The Senior Validation Engineer is responsible for managing, developing and implementing Equipment and  Facility Validation program to ensure compliance with regulatory agency requirements, internal company standards and current industry practices

This is a full-time position: Monday – Friday, 8:00AM – 5:00PM

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.

Catalent in Somerset, NJ is home to oral solid dose manufacturing operations as part of the Oral and Specialty Delivery (OSD) business unit. On site we have our state-of-the-art laboratory, clinical, and commercial manufacturing plant for oral dose forms in addition to being the Catalent Center of Excellence for handling Highly Potent Active Pharmaceutical Ingredients.

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

• Design, develop, and lead Equipment and Facility Validation initiatives
• Ensure that the Validation Master Plan remains current
• Prepare and execute IQ/OQ/PQ protocols for equipment, instrument, facility, and utilities (HVAC, Building Automation System, Compressed Air, Nitrogen system, and Environmental Monitoring) as well as related software to ensure compliance and adherence to CGMP and Catalent validation standards
• Identify and resolve non-conformances/deviations encountered during IQ/OQ/PQ execution and work with supervisor to implement mitigation solution
• Help generate qualification report and help summarize the results which will be reviewed by the supervisor
• Perform re-qualification of equipment, facility, and utilities as per change control requirements
• Initiate problem reports (change control, CAPA, etc.) in TrackWise system
• Facilitate a continuous improvement culture within the Manufacturing, Engineering and Quality Control/Assurance environments
• Generate and maintain Validation procedures in line with corporate guidelines procedures, CGMP and ISPE standards
• Review change control, SOP’s, calibration, preventative, and corrective maintenance documentation for equipment/system to assure that all remain in a validated state
• All other duties as assigned;

The Candidate

• Bachelors degree in a technical or scientific discipline is required, Masters degree preferred
• Five or more years of experience in a Validation role or related is required
• Experience in a CGMP regulated industry is strongly preferred
• Experience working with oral solid dosage is preferred
• Working knowledge of the Code of Federal Regulations and Validation cGMPs is strongly preferred
• Prior experience leading validation project teams is preferred
• Prior experience writing technical documents is preferred

• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;

Why you should join Catalent:

• Defined career path and annual performance review and feedback process 
• Diverse, inclusive culture 
• 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 
• 152 Hours + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Community engagement and green initiatives 
• Generous 401K match 
• Company match on donations to organizations
• Medical, dental and vision benefits effective da