Senior Cleaning Validation Specialist

Senior Cleaning Validation Specialist

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 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