Engineer Equipment
Resume:
David L. Blumberg
Bridgewater, NJ *****
*****.************@*****.***
Senior Validation Engineer
SUMMARY
Extensive experience in pharmaceutical, biotechnology, and medical device industries. Broad knowledge of equipment validation including autoclave sterilization and temperature mapping. Want to utilize my pass strengths but also provides challenges to expand my knowledge within the validation field.
PROFESSIONAL EXPERIENCE
Renaissance (DPT)
Validation Engineer 5/16 – 6/17
Write validation protocols (PQ & RQ) and reports. Calibrate and execute validation test equipment (data loggers and thermocouples) for sterilization activities.
Steam – Autoclaves
Dry Heat – Depyrogenation Oven
VHP – Isolator
Perform Temperature/Humidity Mapping Studies on the following equipment:
Warehouses
Refrigerators
Freezers
Merck, West Point, PA
Validation Engineer 2/16 - 4/16
Automatic Inspection Machine (AIM) for 3 mL glass vials with a speed of 400 vials / minute
Wrote an Installation and Operational Qualification (IOQ) protocol
Executed the IOQ on the AIM
Completed the internal review process for the IOQ report
Roche Molecular System, Branchburg, NJ
Senior Validation Engineer 2005 - 2015
Responsible for establishing a Requalification (RQ) program for the following equipment:
Autoclaves, Walk-In Controlled Temperature Units (CTU), Fermenters and met all deadlines
Developed a schedule to complete tasks on an annual basis and establish a RQ program for over 30 pieces of equipment.
Trained 6 employees one on one to complete RQ on time. The training included protocol writing, temperature mapping and final reports.
Ensured 25 final reports were completed annually to satisfy FDA mandate
Subject Matter Expert (SME) on Sterilization and Temperature Mapping:
Equipment Includes: Autoclaves, Fermenters, Ovens, Refrigerators, -20 and -80C Freezers, Liquid Nitrogen Freezers, Incubators
Temperature Mapping includes Walk-in and Stand-alone equipment to meet FDA requirements
Understand Sterilization Parameters: Fo, Z-value, D-value to program validation equipment and analyze data.
Microbiology experience to set up a Biological Indicator (BI) Program to support autoclave validations
Expert on Validation Equipment - Validator 2000 (V2K) and ValProbes (data loggers):
Conducted training courses on validation test equipment for 6 employee personnel. Developed training and administered for new employees and contractors.
Programmed the V2K and ValProbes on a weekly basis to execute validation studies and complete reports.
Experience includes Resistance Temperature Detector (RTD), Sensor Input Module (SIMs), Temperature Baths, Preparation of Thermocouples, Calibration
Manager of a medium Validation Workshop (130 pieces of equipment) to provide calibrated equipment to the Validation Engineers. The goal was to ensure the Backlog (track instruments) did not contain uncalibrated validation equipment.
Wrote 5 SOPs for the operation of the critical validation test equipment. The SOPs were reviewed on a 3 year cycle by the validation department and updated if necessary.
Extensive experience with autoclaves:
Final autoclave cycles were established by completing Cycle Development (CD), IOQ, PQ, RQ activities for 6 autoclaves.
Developed a validation program starting from the autoclave installation to owner assuming responsibility of autoclave.
Supervised 5 contractors over a 1 year period to complete autoclave validation on time
Traveled to Switzerland to train colleagues on autoclave cycle development and empty chamber runs. Designed training and material used to train colleagues.
Organon, West Orange, NJ
Senior Validation Engineer 2002 – 2005
Responsibilities
Worked on a team to design, construct, and validate a parenteral facility with a high speed vial line. Responsible for the validation of the new facility.
Participated in weekly meetings with 15 people to contribute the validation on this project
Traveled to Germany with the team to discuss production equipment with manufactures and selected a contractor
Responsible for the process equipment and cleaning validation of the entire parenteral facility including the vial line
Wrote Process Validation Plan (PVP) to outline the action steps of the projects
Wrote protocols, execute protocols, and wrote reports for parenteral equipment. This includes autoclaves, ovens and filling machines.
Responsible for the validation of new equipment purchased for the existing facility.
Validated Fedegari autoclaves from purchase, FAT, Installation, SAT and writing, IQ, OQ, PQ, execution and the corresponding reports
Terminal Sterilization experience for finished vials at pre-determined parameters.
Mentored a junior engineer in basic sterile validation for 3 months
Train 3 colleagues in Aseptic Processing
Certified in sterile gowning training and passed the in-house test.
Led Factory Acceptance Test (FAT) effort for production equipment to select the optimal equipment
Wrote Work Instructions and SOPs for Parenteral equipment
Technical Transfer
Project Leader responsible for the transfer of a lyophilized product from New Jersey to Indiana and monitored the time and temperature throughout the shipping.
Wrote the Site Transfer Plan which is similar to a Master Plan that defines the entire process for both companies
Shipping Studies
Worked with outside company to define the acceptance criteria of the cardboard boxes being shipped
Boxes are placed in an environmental chamber to simulate the Winter and Summer conditions. This ensures accurate shipping for all seasons.
The product inside the box must meet the time and temperature requirements that are established in the protocol.
Pfizer (formerly Warner Lambert / Parke-Davis, Morris Plains, NJ)
Scientist 1995 - 2002
Responsibilities
Worked on a project team of 12 people to develop a parenteral drug from phase I to the filing of the New Drug Application (NDA).
Conducted compatibility and stability studies to provide data for the NDA and found the drug passed the acceptance criteria.
Formulation Development responsibility for the successful scale-up and the technology transfer from New Jersey to Ireland to prepare for the manufacturing and the Pre-approval Inspection (PAI).
Wrote research reports summarizing the formulation history from conception in Japan to the U.S. market
Presentation to senior management every 2 weeks to discuss project time lines and future goal setting
Responsible for the requalification of a Parenteral Facility
Set up organizational meetings bi-weekly with 4 critical department managers to explain how this new validation project would be completed
Wrote, executed and summarized data in protocols and reports
Wrote and reviewed SOPs for the parenteral facility
Responsible for coordinating the calibration, preventative maintenance and repairs to maintain a cGMP Facility
Wrote a Validation Master Plan as a tool for management to understand the validation history in the Facility
Validated 5 isolators for a parenteral facility using Vaporized Hydrogen Peroxide (VHP).
Experienced in VHP, steam and filtration sterilization to validate isolators, autoclaves and filters
Lyophilization expertise including research and commercial size equipment
Research on a Cryostage microscope to duplicate lyophilization conditions on a microscope scale and was able to demonstrate in front of supervisors and record the state changes.
PRIOR EXPERIENCE
SmithKline Beecham, King of Prussia, Pennsylvania
Validation Engineer
Life Sciences International, Philadelphia, Pennsylvania
Validation Specialist
Eli Lilly and Company – Indianapolis, Indiana
Ortho Pharmaceuticals – Manati, Puerto Rico
Amgen – Thousand Oaks, California
Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
Senior Medical Technologist
EDUCATION
Pennsylvania State University
Bachelors of Science, Biology, Pennsylvania State University
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