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 initiativesEnsure that the Validation Master Plan remains currentPrepare 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 standardsIdentify and resolve non-conformances/deviations encountered during IQ/OQ/PQ execution and work with supervisor to implement mitigation solutionHelp generate qualification report and help summarize the results which will be reviewed by the supervisorPerform re-qualification of equipment, facility, and utilities as per change control requirementsInitiate problem reports (change control, CAPA, etc.) in TrackWise systemFacilitate a continuous improvement culture within the Manufacturing, Engineering and Quality Control/Assurance environmentsGenerate and maintain Validation procedures in line with corporate guidelines procedures, CGMP and ISPE standardsReview change control, SOP’s, calibration, preventative, and corrective maintenance documentation for equipment/system to assure that all remain in a validated stateAll other duties as assigned;

The Candidate

Bachelors degree in a technical or scientific discipline is required, Masters degree preferredFive or more years of experience in a Validation role or related is requiredExperience in a CGMP regulated industry is strongly preferredExperience working with oral solid dosage is preferredWorking knowledge of the Code of Federal Regulations and Validation cGMPs is strongly preferredPrior experience leading validation project teams is preferredPrior experience writing technical documents is preferredIndividual 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 innovativePotential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 Hours + 8 paid holidaysSeveral Employee Resource Groups focusing on D&IDynamic, fast-paced work environmentCommunity engagement and green initiatives Generous 401K match Company match on donations to organizationsMedical, dental and vision benefits effective day one of employment Tuition Reimbursement – Let us help you finish your degree or start a new degree!WellHub program to promote overall physical wellness Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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.

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.