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Engineer Equipment

Location:
Uswick, Pennsylvania, 18438, United States
Posted:
January 21, 2019

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Resume:

David L. Blumberg

Summary:

Experienced equipment Senior Validation Specialist in the pharmaceutical, biotechnology, and medical device industries.

Years of cGMP experience in the Validation Life Cycle approach to equipment and cleaning validation. Expertise includes: writing protocols (IQ, OQ, PQ, & RQ), execution of protocols and writing reports.

Validation documentation consists of Deviations, Standard Operating Procedures (SOP), Corrective Action/Preventative Action (CAPA), Change Control and User Requirement Specifications (URS).

Work with internal departments including Quality Assurance, Engineering, Microbiology and Manufacturing to ensure all protocols and reports are approved and available for regulatory (FDA) audits.

Responsible for establishing a Requalification (RQ) program for the following equipment:

Autoclaves, Walk-In Controlled Temperature Units (CTU), Fermenters and met all deadlines

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.

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.

Assigned to equipment validation, process validation and cleaning validation projects.

Education:

Pennsylvania State University

Bachelors of Science, Biology

Professional Experience :

Unither, Rochester, NY Aug 2018 – Dec 2018

Validation Engineer

Unither is a Contract Manufacturing Organization (CMO) that produces solids, liquids and sterile products. Assigned to equipment validation, process validation and cleaning validation projects.

Write protocols, execute protocols and write reports. Interact with various departments (e.g. Manufacturing, Quality Assurance) within the company to get the protocols and reports approved. Examples of the Unither Manufacturing equipment are as follows:

Glatt GPCG-60 (Bead Coating) – IOQ and PQ protocols and reports

Glatt GPCG-60 (Bead Coating) – Cleaning Validation (visual, swab and rinse samples)

Blow Fill Seal (BFS) technology – CIP, SIP and cleaning validation

Controlled Temperature Unit (CTU) - Temperature Mapping (data loggers)

Checkweigher XE2 and Pumps – Equipment Validation

Manufacturing Bottle Lines – Process Validation

Renaissance (DPT), Lakewood, NJ May 2016 – Jun 2017

Validation Engineer

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

Incubators

Merck, West Point, PA Feb 2016 – Apr 2016

Validation Engineer

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 2005 - 2015

Senior Validation Engineer

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

Subject Matter 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 2002 – 2005

Senior Validation Engineer

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.

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.

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.

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

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) 1995 - 2002

Scientist

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, dry heat and filtration sterilization to validate isolators, autoclaves, ovens 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.



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