Pharmaceutical Process and Cleaning Validation Expert Consultant Resume
Resume of OBD Consultant

  • Biotechnology
  • Pharmaceutical
  • Validation

This expert has a B.S. in Industrial Engineering from the University of Puerto Rico, Mayaguez Campus.

Pharmaceutical Process and Cleaning Validation Expert Consultant Resume

This expert specializes in project management in the pharmaceutical / biotechnology manufacturing environment.

This expert has extensive experience working in the validation field with a strong background in Project Management, Process Validation, Cleaning Validation (CIP Skids and distribution System & SIP), and Equipment/Environmental/Utilities Validation. Further experience and knowledge includes Temperature Studies, Microniser, CIP Systems, Smoke Profile Studies, Regulatory Compliance and Manufacturing Process support for the Pharmaceutical Industries.

This consultant has experience working with manufacturing and packaging processes for creams, suspensions, solid dosage, parenterals (Bio-tech) and active pharmaceutical ingredients (API).

Consultant, Kevin Kennedy Associates Inc.

Providing expertise in validation, pharmaceutical process and cleaning validation, project management in the pharmaceutical / biotechnology manufacturing environment, and related expertise to a wide variety of clients.


Execution Lead / Senior Validation Specialist, Lilly PR06, Guayama PR

Worked in the development and execution of Installation Commissioning documents, Functional Testing documents, IOQ Protocols for Reactors, Purified Water System, Nitrogen Supply System, IPA Storage and Distribution System, Water for Operation System, and HCl Storage. Led execution activities and operators during 12 hours shifts in order to comply with project priorities and schedule. Conducted IQ/OQ, Lactose Trials and Engineering Trials for Building 25 Microniser System. Responsible for development and execution of IOQ protocol for Microniser CIP System.


Senior Validation Specialist, Bristol Myers Squibb, Manati Plant MSR Project

Developed and executed the following documents: Vent System IQ, Installation Commissioning, Operational Commissioning and IOQ Protocol for Mork Portable CIP Unit, IOQ for Buffer and Process Tanks, IOQ for Floor Scales and Bench Scales.


Senior Validation Scientist / Project Manager, Lilly del Caribe, Inc., PR05 Plant NBHF Project

Was responsible for development and execution of Pre-OQ and OQ for CIP Circuits. Development of Commissioning IV/OV documents, and IQ/OQ protocols for Fermentation Building Sub-systems controlled by Delta V Control System, that included but were not limited to: Jacketed Feed / Recycle Tanks, CIP Systems, Variable Speed Pumps, Homogenizers, Main Fermentors, Seed Fermentors, Variable Speed Agitators, Heat Exchangers, Electrical Heaters, Temperature Control Systems, OIT Screens, Exchangers, CIP Mobile Units, Homogenizers and Autoclaves, Delta V Control System. Execution of Cleaning Validation Area in the Purification Building Equipment (Tanks, LHMs, and Chromatographic Columns).


Senior Validation Scientist, Cardinal Health, Humacao, PR

Led, developed and executed the Validation Master Plan of new products (terminal sterilization, ophthalmic and blow fill seal processes) including sterilization, process validation and cleaning processes. Responsible for validation of Ethylene Oxide sterilization process in Steri-tech facility.


Project Manager / Validation Engineer, Amgen Mfg. Ltd. (Juncos) and Lilly del Caribe PR02, Carolina, PR

Project management related activities inclued development and execution of IQ/OQ/PQ protocols and reports for Vials and Syringes Packaging Lines. Design and execution of qualification protocols for Reactors, Level Radars, PK Blenders, Tray Washer Machine, Portable Tanks and a Tumble Blender. Preparation and execution of qualification protocols and reports for Bio-chemical manufacturing equipment. Preparation of reports for Heat Distribution studies conducted in empty fermentors. Project management related activities for a parenteral product launch (packaging project).


Technical Services Scientist, J&J Pharmaceutical Partners, Gurabo PR

Responsibilities included design and execution of validation protocols (DOE, Scale up process validation, Characterization Studies). Coordination of validation activities with related areas, samples collection, data analysis and preparation of validation summary reports. Preparation of Technical Services Batch Records for Experimental, Developmental and Validation purposes. Preparation of IQ/OQ/PQ protocols and reports for manufacturing and packaging equipment. Development of operating and cleaning procedures (SOPs) for Manufacturing Equipment. Preparation/revision of SOPs for handling and manufacturing of Controlled Substances in order to comply with DEA regulations.


Project Engineer, Johnson & Johnson Strategic Visioning Projec, Gurabo PR

Provided support to all the activities related to the assessment of Johnson & Johnson current operations in Puerto Rico and to the design of a strategy to assure competitiveness which involved: data gathering, benchmarking, revision of current manufacturing technologies, leverage of resources and visits to all facilities of Johnson and Johnson Puerto Rico Operations.


Temporary Training Department Leader, Technical Training Specialist, Syntex, Humacao, PR

Responsible for development of job curricula for personnel working in the Manufacturing, Quality and Engineering Departments. Preparation of technical training manuals designed for certification purposes. Coordination of in-house and off-site training sessions with vendors and/or consultants. Design and development of a Job Skills Certification Program for manufacturing employees, which involved cross training activities.


Manufacturing Technologist, Warner Lambert, Inc., Vega Baja, PR

Duties included execution of process validation protocols for granulation, compression, and coating stages of solid dosage consumer products. Revision of Standard Operating Procedures and preparation of Master Batch Records for pharmaceutical and consumer products. Preparation and execution of qualification protocols and reports for manufacturing equipment.

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


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