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 is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 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 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.
