Senior Validation and Sterile Manufacturing Expert Consultant Resumes
{/sliders}
Resume of WUR Consultant
{/sliders}

  • Biotechnology
  • Pharmaceutical
  • Sterile Manufacturing
  • Packaging
  • Validation

This expert has a B.S. in Chemistry from the University of Puerto Rico, Cayey Campus.

Senior Validation and Sterile Manufacturing Expert Consultant Resumes

This expert specializes in the pharmaceutical industry. This expert has hands-on experience in the development of manufacturing and laboratory protocols, product transfer and special projects.

Cross-functional experience of this expert includes supervising filling and packaging operations, and validation and sterilization processes. This expert is capable of working under pressure within a fast-paced environment, communicating effectively at all levels and interacting supportively within a team environment.

Consultant, Kevin Kennedy Associates Inc.

Providing expertise in validation, sterile manufacturing, manufacturing and laboratory protocols, product transfer, filling and packaging operations, and related expertise to a wide variety of clients.

 

Senior Validation Specialist, Bristol Myers Squibb Co., Manati, PR

Prepared and executed PQ protocols for the qualification of the Filling/ Formulation Equipments and Components for a sterile manufacturing process. Coordinated the activities with other departments and suppliers for the successful execution and approval of the validation protocols associated with the sterile manufacturing. Investigated and resolved deviations and investigations from Sterilization Process and Revalidations Studies. Supported investigation to determine root cause, developed corrective and preventive actions implementation. Provided technical assistance to Validation Scientist in performing documentation reviews. Reviewed Standard Operating Procedure for the Sterilization and Depyrogenation Cycle Development, Validation and Revalidation V 15.00 to reflect new process design and cGMP’s.

 

Senior Validation Specialist, Biovail Laboratories Inc., Dorado PR

Accomplished two Product Process Transfer from Biovail’s Carolina facilities to Dorado, following FDA’s SUPAC Guidelines for Immediate Release Solid Oral Dosage forms. Prepared and executed IQ, OQ and PQ protocols for the qualification of the Solid Dose Manufacturing for a new product transfer. Investigated and resolved deviations and investigations from the Solid Dose Manufacturing and Packaging Departments. Communicated to the Manufacturing Director issues and recommendations on effective corrective and preventive actions. Prepared new Standard Operating Procedures for the Packaging Departments to reflect new process design and cGMP’s.

 

Consultant, Senior Validation Specialist, Aventis

Prepared and executed IQ, OQ and PQ protocols for the qualification of the manufacturing and Microbiological Laboratory autoclaves. Designed sterilization load to reduce the bioburden in the manufacturing equipments. Prepared new Standard Operating Procedures for the manufacturing Departments to reflect new sterilization process design and cGMP’s. Provided necessary training, coaching and counseling to manufacturing and laboratory personnel.

 

Protocol Specialist, Schering Plough Products, L.L.C., Manati, PR

Reported to the Technical Transfer Manager, with full responsibilities for manufacturing protocols preparation, products transfer and special projects. Developed manufacturing protocols and summary reports for qualification of critical modification and approval of regulatory, validation, stability and technical services areas. Prepared process capabilities studies for new products. Prepared the Variance Investigation Report (VIR) for events against regulatory commitments. Developed new product specifications and revised master batch record. Coordinated, along with purchasing department, the materials availability for the manufacturing process. Coordinated and revised the sampling plans for final product evaluation.

 

Sterilization Supervisor, Schering Plough Products, L.L.C., Manati, PR

Reported to the Sterile Process Manager with responsibilities for plan, schedule and supervise all sterilization operations. Planned, scheduled and supervised all sterilization operations for equipments (filling and compounding), stoppers, ethylene oxide loads and uniforms. Coordinated the preparation of stoppers. Maintained and controlled uniforms, plastic components and sterile stoppers inventory. Prepared stoppers and plastic components manufacturing order using Materials Requirement Planning (MRP) system. Performed experimental design for stoppers troubleshooting. Prepared variances reports. Prepared and reviewed SOP’s. Supervised 11 employees

 

Sterile Fill/Pack Supervisor, Schering Plough Products, L.L.C., Manati, PR

Reported to Sterile Fill/Pack Manager with responsibilities for coordinating and organizing all filling and packaging operations and provide training and coaching to assigned personnel. Coordinated and organized fill and packaging operations in accordance to production schedules. Prepared production schedules to assure personnel and equipment availability. Supervised fill and packaging operations to ensure compliance with established procedures. Provided necessary training, coaching and counseling to assigned personnel. Prepared and revised SOP’s.

 

Validation Analyst, Schering Plough Products, L.L.C., Manati, PR

Reported to Validation Manager with responsibilities for products transfer, equipment validation, development of project protocols and provide technical support to manufacturing department. Developed and implemented validation protocols for sterilization process (steam in place (SIP), ethylene oxide gas (ETO) and dry heat), filling pump, product transfer lines, bulks, filters sterilization, ampules, vials depyrogeneation and Hydrogen Peroxide Vapor (VHP) sterilization. Developed project protocols, special studies and validation reports for sterile and non-sterile products. Coordinated the product transfer of Afrin Nasal Spray from New Jersey to Manati, Puerto Rico. Performed internal environmental and utilities validations studies for laminarity and smoke profile, High Efficiency Particular Air (HEPA) filters certifications, nitrogen, clean steam, compressed air, purified Water for Injection (WFI) and Dionized Water (D1W). Provided technical support to manufacturing department in validation, revalidation and specification of equipment. Prepared validation reports.

Let us quickly locate the best and most qualified expert or expertise you need.

800-700-4944

Full Name*
Please fill in the required field.

Email*
Please fill in the required field.

Phone*
Please fill in the required field.

Company
Please fill in the required field.

Client Need
Please fill in the required field.

Invalid Input

FEATURED CONSULTANT

Peter Habicht, Lead Consultant
Peter specializes in welding and metallurgical engineer with 40 years industry experience in commercial nuclear power plant construction.

CONSULTING OPPORTUNITIES

  • Poly(methylmethacrylate) Manufacturing Operations / Processes Consultants
  • Cell Phone Technologies Expert

RAPID RESPONSE

Our Business Model
At Kevin Kennedy Associates, we’ve revolutionized the consulting business by streamlining the way our clients interact with experts.