Senior Cleaning Validation Specialist

Catalent Pharma Solutions • St. Petersburg, FL

5d • Onsite

About The Position

Senior Cleaning Validation Specialist Position Summary Work Schedule: Standard Hours; Monday through Friday 100% on-site Join Catalent’s flagship softgel development and manufacturing facility in North America, located in St. Petersburg, FL, with a capacity of 18 billion capsules per year. This role offers competitive pay, day-one benefits, and career growth in a state-of-the-art, turn-key facility. 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 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.

Requirements

• 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.

Responsibilities

• 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.

Benefits

• Tuition reimbursement to support educational goals
• WellHub program to promote physical wellness
• Access to Perkspot discounts from over 900 merchants
• 152 hours of PTO plus 8 paid holidays
• Medical, dental, and vision benefits effective day one
• Defined career path with annual performance reviews & strong potential for career growth within a mission-driven organization
• Inclusive culture with active Employee Resource Groups & Community engagement and green initiatives

What This Job Offers

• Job Type: Full-time
• Career Level: Senior