Technician Operator

Vincent El Dennis

Summary

-Pharmaceutical Associate with over 13 years’ experience working in cGMP environments.

-Solid instrument troubleshooting capabilities.

-Skilled in complex preparation of biopharmaceutical intermediates.

-Experienced with manufacturing operations following SOPs and batch document instructions.

Education

Abington Senior High School Abington, PA

EXPERIENCE

Merck West Point, Pa

Support Associate Level 2, May 2018- October 2018

Maintain areas in compliance with cGMPs and other applicable regulatory guidelines by performing all necessary housekeeping, disinfection, and waste management of assigned production environments.

Adheres to all MERCK safety guidelines and procedures.

Monitor facility conditions during activities defined above and perform general tasks to ensure the environment and equipment are maintained in full regulatory compliance. Tasks will include, but are not be limited to equipment cleaning and minor surface repairs using co-on hand tools Notify supervisor or other designate of areas requiting further attention

Aligned with production activities, will assist others in removing used process equipment or assisting with the breakdown of equipment following completed operations.

Maintain appropriate GMP documentation for all responsible activities and ensure compliance with all training requirements

Using appropriate data management systems, manages and ensures inventory of all necessary production and support supplies.

Performs all tasks required to ensure a supply of sterile and/or cleaned equipment, including, but not limited to

CIP of equipment using manual and automated equipment washers and wash systems.

Ste1ilization activities using autoclaves and Distributive Control Systems. Dehydrogenation activities using D1y Heat Ovens

In compliance with manufacturing requirements, prepares and sterilizes growth media buffers and other solutions used in production processes.

Prepares and sterilizes process equipment.

Inte1faces with Distributed Control System to control cleaning, sterilization, and manufacturing operations

Experience working in a cGMP, clean room, and/or aseptic environment

University of Penn Philadelphia, PA

Lab Facility Technician, June 2016 – August 2016

In charge of cleaning and decontamination of labs.

GLP and cGMP environment.

Maintained accepted conditions compliant with FDA guidelines.

Biohazard waster, disposal, autoclave.

Changeover of tissue culture room as needed.

Floor Mopped, changed CO2 and liquid nitrogen. Unpacked inventory.

Managed and stocked clinical reagent inventory.

Adhered to cGMPs while following SOPs.

AstraZeneca Philadelphia, PA

Manufacturing Technician, March 2015 – November 2015

•Aseptic Cleaning

-Performed dilution of cleaning agents namely Spor-klenz, LPH, Vesphene and Decon.

-Aseptically cleaned controlled areas using a double bucket system, sanitizing rooms from the farthest point to the entrance starting with higher grade rooms.

•Stage Technician

-Inspected final products for rejection and defects.

-Performed 100% reconciliation of acceptable and rejected products.

-Worked in downdraft hood (BSC) using aseptic techniques.

-Operated Paternoster machinery via an HMI.

-Practiced clean room behavior at all times.

•Thaw Technician

-Handled frozen monovalent bulk via 80 freezers

-Thawed (defrosted) materials in a walk in 30 degree thaw chamber according to SOPs

-Aseptically transferred final thaw products to higher grade controlled areas while monitoring airflows and differential pressures.

Adhered to cGMPs while following batch records and SOPs.

Axcentria Pharmaceuticals, LLC Telford, PA

Clinical Packaging, Nov 2013 – Feb 2014

Performed all tasks related to clinical packaging.

Signed and dated charts, all critical packaging steps and work order documentation.

Periodic Quality inspections during packaging process.

Ensured that each component or bulk material used in the packaging of a product was properly identified, not expired, weighed (when appropriate), verified throughout processing and corresponded to the written information on the work order before proceeding to the next step.

Adhered to cGMPs while following batch records and SOPs.

Almac (Temporary) Audubon, PA

Clinical Pharmaceutical Technician, Sept 2013 - Nov 2013

Performed all tasks related to clinical packaging while following health and safety guidelines (used personal protective equipment as required), respected specialist cGMP’s for Investigational products, adhered to the work order instructions and SOPs.

Ensured that each component or bulk material used in the packaging of a product was properly identified, not expired, weighed (when appropriate), verified throughout processing and corresponded to the written information on the work order before proceeding to the next step.

Verified before use that equipment calibration date had not been exceeded.

Signed and dated utilization charts and all critical packaging steps in the work order documentation.

When necessary, countersigned as an independent observer.

Performed quality verifications and equipment challenge tests.

In addition carried out all the periodic quality inspections during the packaging process in order to ensure that the integrity and efficacy of the finished goods.

Adhered to cGMPs while following batch records and SOPs.

Aqua America, Inc. Willow Grove, PA

Laborer, July 2012 - Sept 2012

Painting fire hydrants using company vehicle

Ok

MedImmune, Inc. Philadelphia, PA

Manufacturing Technician, March 2008–Oct 2008

Performed aseptic technique and practices.

Adhered to cGMPs while following batch records and SOPs.

Clean in Place and Steam in Place of 120L and 200L Feldmeier blend tanks.

Operation of the Yokogawa DR240 chart recorder and SIP manifold.

Operation and use of the controlled thaw chamber.

Aseptic gown qualified in both the class 10,000 and class 100 areas.

Prepared and handled materials for sterilization.

Performed fill weight check verifications.

Adhered to cGMPs while following batch records and SOPs.

Centocor, Inc. Malvern, PA

Lab Technician, April 2005–March 2008

Performed assembly of sterile bioreactor parts and completed inventory.

Used 30L Bioreactors, autoclave, agitators, centrifuge and washers.

Prepared media and buffers.

Growth, harvest, isolation and inoculation.

Assembled, disassembled, and cleaned bioreactors.

Calibrated Masterflex pumps.

Maintained compressed gasses for laboratories.

General clean up and maintenance of bioreactor station.

Logged equipment.

Assisted in sampling of bioreactors.

Monitored refrigerators and incubators.

Completed inventory for the laboratories.

Adhered to cGMPs while following batch records and SOPs.

GlaxoSmithKline Conshohocken, PA

Process Operator, May 2004–August 2004

Aseptic filling.

Sanitized the aseptic area.

Operation of the Fedegari Autoclave.

Operation of the Dispatch Oven.

Deactivation of the Cytotoxic Aqueous Waste.

Adhere to cGMPs while following batch records and SOPs in a timely manner.

McNeil CS&P Ft. Washington, PA

Production Operator, May 2003–May 2004

Performed line monitor duties.

Supplied material for solid dose bottles.

Completed inventory of components prior to and during line operation.

Palletized, wrapped, and transported product skids via hand truck to staging area.

Completed documentation review. Provided on the floor quality assurance.

Used the SAP system to register and assign materials to production areas.

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