Validation Engineer II
Position Summary
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's Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development.
The Validation Engineer II will primarily support and work directly with operations, clients, information technology/automation, engineering, stability/logistics, and quality to ensure processes (manufacturing, packaging, and cleaning), equipment, systems, and facilities are qualified and continued to be maintained in a validated state.
Regular working hours: Monday - Friday; 8:00 AM-4:30 PM or 8:30 AM-5:00 PM with a 30-minute unpaid lunch.
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
Author/Review process validation protocols and validation summary reports for Process, Cleaning, Computer and Engineering (Equipment, Facilities, Utilities) Validation. Perform validation testing and analyze data for validation documentation to determine acceptability, identify deviations and make appropriate notification
Client Validation representative for product validations. Attend meetings and support client questions and requests associated with product validation and Continued Process Verification.
Create product monitoring plan protocols, collect & statistically analyze batch data, compose CPV documentation such as product dashboards and reports.
Periodic Review, Mapping, Remapping, and Revalidation for Equipment and Utilities.
Use a validation life cycle approach and follow the site master validation plan.
All other duties as assigned
The Candidate
Bachelor’s degree in Technical or Life Sciences discipline with at least 2 years of experience in the pharmaceutical industry (or) Associate degree in Technical or Life Sciences discipline with at least 4 years of experience in the pharmaceutical industry is required.
1+ year’s of validation experience is preferred.
Some exposure to hazardous chemicals and other active chemical ingredients
Position requires the capacity to handle and manipulate objects using hands and arms
This position requires that a respirator be worn for your safety, and as such, employment is contingent upon being able to complete a medical evaluation with satisfactory results. The medical evaluation is conducted via an external vendor assigned by Catalent.
Why You Should Join Catalent
Medical, dental, and vision insurance.
401(k) retirement savings plan with company match.
Fast-paced, dynamic environment.
152 hours of PTO + 8 paid holidays.
Opportunity to work on Continuous Improvement Processes.
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.
