Expert Details

Expert in Equipment Validation

Expert ID: 733783 Missouri, USA

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Experienced pharmaceutical process engineer with demonstrated ability in managing, supporting, and formulating in a dynamic environment.

EQUIPMENT EXPERIENCE
 Ackley Imprinter
 Glatt - GPCG-1, GPCG Pro-5, VG Pro 65, Midi Glatt, VG-25, Glatt SKS-100 valves.
 Korsch - XL400WIP, XL100 tablet press, XM12 (B & D turret).
 Romaco/Killian - STYL’ONE Evo single stroke multi-layer tablet press.
 Vector LDCS-5 - coating pans (0.5 – 8.0 L) Pilot HI-COATER, Nica E140 extruders and Nica S450 / S700 spheronizers.
 Vector - FLM-1, FLM-3, FLM-30. FLM-120 and FLM-300, Lab Mini Fluid Bed, TF-Mini Roller Compactor.
 IMA - GS Evolution LAB 30 Coater (solid wall).
 PK-MVP Blending station utilizing 10, 5, 3, 2, and 1cubic ft. blending shells, Lab Master Blender.
 Experience with hot-melt congealing (spinning disc) PX30, PX100, and PX400, Riva Piccola tablet press (10-station).

Education

Year Degree Subject Institution
Year: 2006 Degree: Bachelors Subject: Business Management Institution: University of Phoenix

Work History

Years Employer Title Department Responsibilities
Years: 2016 to Present Employer: Undisclosed Title: Process Engineer Department: Responsibilities:  Job Responsibilities:
° Write level 3 Standard Operating Procedures (SOPs) with photos to provide detailed process work instructions (PWI’s) and/or cleaning work instructions to manufacturing personnel. This is accomplished by utilizing equipment manuals, observation of manufacturing processes, attendance of vendor provided equipment training, and conducting interviews with operators and supervisors, as needed.
° Execute and participate FAT’s, SAT’s and validation protocols including performing Installation Qualification (IQ) and Operational Qualifications (OQ) for a Buhler Extruder process, and setting up a Marchessini packaging line
° Initialize change controls and drive them through to approval/completion stage.
° Adhere to domestic and international GMP regulations.
Years: 2015 to 2016 Employer: Alkem Laboratories Ltd. Title: Senior Manufacturing Supervisor Department: Responsibilities:  Job Responsibilities:
° Supervise employees who tend automatic/manual equipment or perform operations to dispense, manufacture, fill and package products, including but not limited to finished pharmaceutical goods.
° Supervise daily operation of production department; see that schedules are met, ensure optimum use of equipment and staff to maximize productivity. Prepare the daily report and report to management.
° Ensures products are manufactured and packaged according to Master Batch Records and current Good Manufacturing Practices (cGMPs).
° Conducts tests and measurements throughout the stages of production to determine control over applicable variables.
° Troubleshoot and solve production process problems with processes and equipment.
° Provide on job training to employees and maintain the training record for all manufacturing employees.
° Ensures employees are trained as necessary and follow company SOPs and policies, cGMP requirements and safety practices.
° Batch record review, participation in nonconformance investigations, root cause analysis and CAPA action plans.
° Write and review SOP, MMR, MPR, Protocol and reports as necessary.
° Ensure manufacturing and warehouse area is in GMP, DEA and Safety compliance.
° Execution of validation protocols as instructed for cleaning processes, equipment qualification and processes/products.
° Maintain the stock for consumable items of manufacturing.
° Organize and manage the temporary employee schedule.
° Responsible for hiring qualified staff to assure corporate policies and procedures.
Years: 2008 to 2015 Employer: Mallinckrodt (formerly Covidien) Title: Equipment Specialist Department: Responsibilities:  Process Improvement and Optimization:
° Assist with the development and validation of OSD products.
° Work closely with research and development and quality assurance personnel to improve manufacturing efficiencies and improve product quality.
° Responsible for oversight for process development, transfer, and scale-up activities.
° Participate on corporate equipment site teams to evaluate and purchase equipment for transfer, scale-up and process improvements for the development of branded/generic products.
° Develop Standard Operating Procedures relating to technology transfer.
° Provide technical support and consultation to Production, Quality, Regulatory Affairs, and other departments as needed.
° Write and execute IQ/OQ/PQ, validation protocols/reports.
 Pilot Plant:
° Write batch records for experimental, scale-up, and clinical campaigns.
° Responsible for developing and harmonizing an internal corporate philosophy that will result in improved standards/guidelines for pilot plant activities.
 General Duties:
° Manage equipment activities within the department including scheduling assignments and resources, to meet project goals, priority assignments and timely calibrations.
° Provided leadership to appropriate staff by ensuring training and expertise to perform assigned functions. Coaches’ co-workers when necessary.
° Technical liaison/representative for the technical center’s production meetings.
Years: 2007 to 2008 Employer: Covidien Title: Formulation Chemist II Department: Responsibilities:  General Duties:
° Design, develop, and trouble-shoot formulations in support of solid dosage R&D projects.
° Use design of experiments to develop and trouble-shoot solid and liquid dosage pharmaceuticals.
° Perform hands-on work with powder blending, fluid bed drier, high shear granulator, tablet press and other formulation equipment to make formulations and scale them up to transfer to manufacturing.
° Troubleshoot formulation and process.
° Perform physical characteristic testing and dissolution testing on dosage forms.
° Clearly communicate status of projects to multi-functional teams.
° Understand and comply with cGMP documentation and SOP requirements as well as site and departmental safety policies.
° DEA approved to work with controlled substances and potent compounds.
° Work effectively in a team environment.
Years: 2006 to 2007 Employer: KV Pharmaceutical Title: Research Associate- R & D Department: Responsibilities:  General Duties:
° Assist formulator’s/scientist in developing solid pharmaceutical oral dosage formulas, primarily controlled release products for both non-ANDA and DESI production. This included pre-formulation and formulation development of Generic and branded products.
° Assist formulator’s/scientist in writing Product Development Reports and other documentation requested by Management.
° Assist in technology transfer from R&D scale up batches to production size batches, and supply manufacturing support of assigned products.
° Perform equipment setup, perform IQ’s and OQ’s
° Process research batches from pilot/pivotal and scale up batches to full scale production lots.
° Equipment/Processes trained on include: Fluid bed processors, Spheronizer, Extruder, Granulators, Tablet Presses, Roller Compacting, and Blending.
° DEA approved to work with controlled substances.
Years: 2005 to Present Employer: Undisclosed Title: Production Weekender Department: Responsibilities:  Operate high speed filling equipment (fillers, packers, and depalletizers). Monitor high-speed equipment, visually and via HMI technology. Support production by: sterilizing fillers, driving fork-trucks, loading supplies, cleaning lines and equipment. Recording process data and perform minor maintenance and troubleshoot of equipment as needed to meet production demand.
Years: 2004 to 2006 Employer: Centocor Biologics (formerly Wyeth BioPharma) Title: Senior Process Technician Department: Responsibilities:  General Duties:
° Participate in the successful technical product transfer from our Leiden, Holland facility.
° Maintain mammalian cells to produce protein then purify that protein at the intermediate level in large-scale purification using ion exchange chromatography: Conduct cell culture maintenance including cell thaws, cell counting, splits, and inoculations.
° Utilize various laboratory equipment (Nephelometry, spectrometer, osmometer) during in process testing.
° Conduct daily monitoring of bioreactors, bioreactor control systems, and all related large-scale production area equipment.
° Create and revise Standard Operating Procedures (SOP’s), Manufacturing Batch Records (MBR’s), Manufacturing Formulation Records (MFR’s), Corrective and Preventative Action Plans (CAPA’s), and associated logbooks.
° Experience in clean room environment utilizing aseptic techniques and performing in a environmental monitoring (EM) program, all while following strict GMP and FDA regulated guidelines.
° Independently investigate and write discrepancy reports.
° Serve as Safety Inspector to perform monthly audits and make correct deficiencies as needed.
Years: 2001 to 2004 Employer: Wyeth BioPharma Title: Process Technician Department: Responsibilities:  General Duties:
° Assist with executing facility startup IOQ validation
° Perform calculations to insure that batches made maintain consistent high quality standards. Stock and inventory supplies and equipment.
° Perform monthly safety inspections/audits and corrected deficiencies as needed. Train Manufacturing Operators, Associates and temporary employees, as necessary.
° Serve as Safety Inspector to perform monthly audits and make correct deficiencies as needed.
Years: 1998 to 2000 Employer: Amgen – Thousand Oaks Title: Manufacturing Operator Department: Responsibilities:  General Duties:
° Successfully completed Pilot Plant startup of the Thousand Oaks Pilot Plant.
° Provided support for a Biotechnology/Pharmaceutical manufacturing facility
° Primary functions included Aseptic Fill, Media/Buffer Preparation, CIP and SIP of Process Tank Systems, General Production Support, Cell Culture activities. Followed Standard Operating Procedures, Manufacturing Procedures, Training Documents, and Task Performance as assigned. Additional responsibilities included preparing equipment for pharmaceutical production; operating process equipment; monitoring production processes; performing trouble-shooting of equipment & processes; performing preventive maintenance tasks.
° Trained manufacturing operators and associates, as necessary; auditing of production areas, logs and batch records for cGMP compliance. Responsible for departmental safety program, performed monthly safety audits, and conducted weekly safety training an inspections.
Years: 1996 to 1998 Employer: Amgen Title: Material Handler Department: Responsibilities:  General Duties:
° Responsible for receiving, processing, and delivery of materials and packages throughout Amgen. Utilizing the J.D. Edwards AMOS Tracking System and the Telxon Digital Tracking System. Process Domestic and International orders via United Parcel Service (Online Professional Service) and Airborne Express. Investigate best viable shipping options from various freight carriers.
° Answer and assist internal and external customer service questions through the receiving order hotline to complete orders in a timely and efficient manner.
° Calculate departmental statistics daily of incoming and delivered parcel daily.
° Perform cycle counts of inventory, inventory adjustments, and inventory transfers.
° Responsible for writing Standard Operating Procedures for departmental processes.
° Train Manufacturing Operators, Associates and temporary employees, as necessary.

Career Accomplishments

Licenses / Certifications
John Cook School of Business - Saint Louis, Missouri March 2006
Saint Louis University - Supply Chain Management Certificate

Fields of Expertise

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