Senior Cleaning Validation Specialist
Position Summary
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’s St. Petersburg is our primary softgel development and manufacturing facility in North America with a capacity of 18 billion capsules per year. The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug candidates. Non-gelatin based OptiShell® and Vegicaps® capsules expand the range of molecules into softgel, ideal for challenging fill formulation. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve your most difficult development and manufacturing challenges
The Senior Cleaning Validation Specialist position involves creating cleaning cycle development strategies for a variety of equipment including process vessels, clean-in place systems, and parts washers. The Senior Cleaning Validation Specialist also responsible for supporting the design, execution and closure of cleaning studies associated with equipment used in the manufacture of drug product intended for human consumption. This validation group within the Quality Assurance department oversees all aspects of validation as they relate to the implementation of relevant projects and their potential impact on product quality and GMP/GLP. The validation department is responsible for ensuring that all facilities, processes, equipment/systems and automated equipment used for GMP/GLP critical purposes are validated and remain in a validated state.
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
Review and revision of existing cleaning processes to identify improvements. Development of cleaning cycles for process vessels, clean-in-place systems, and part washers.
In conjunction with product development develop procedure for determining solubilities of new APIs in different solvents to support development of appropriate cleaning cycles. Identification and on-boarding of alternate detergents.
Development of cleaning batch records or cleaning checklists to be used to document cleanings were performed according to procedures.
Updating of production procedures, as necessary, to reflect the developed cleaning cycles. Support the design, execution and conclusion of studies that pertain to cleaning verifications / validations.
Coordinate all validation activities with internal departments, while providing customer service and support to the manufacturing process.
Author validation documentation including, but not limited to, Cycle Development Protocols / Reports / Procedures, Cleaning Verification / Validation protocols and reports, Cleaning Assessments and Matrices, and Protocol Discrepancies and Addenda.
Other duties as assigned.
The Candidate
Bachelor’s degree in Science or Engineering required.
5+ years’ experience in the pharmaceutical industry performing cleaning cycle development and validation required.
Strong written and oral communication skills required.
Knowledge of pharmaceutical manufacturing processes and cGMP required.
Familiar with Microsoft Word and Excel.
Ability to solve problems with little guidance. Ability to identify most efficient method in order to achieve predetermined objective. Ability to work effectively under pressure with constantly changing priorities and deadlines. Individual may be required to sit, stand, walk regularly and occasionally lift to 15 lbs; no lifting greater than 44.09 pounds without assistance. Specific vision requirements include reading of written documents and use of computer monitor screen frequently. Ability to work extended hours or off-hours as required.
Why You Should Join Catalent
Tuition Reimbursement – Let us help you finish your degree or earn a new one!
WellHub program to promote overall physical wellness.
152 hours of PTO + 8 paid holidays.
Medical, dental and vision benefits effective day one of employment.
Defined career path and annual performance review and feedback process.
Diverse, inclusive culture. Several Employee Resource Groups focusing on D&I. Community engagement and green initiatives.
Dynamic, fast-paced work environment.
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.
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:
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