MARIETTA M. PUGAL

**** ***** **** *****

Escondido, CA 92025

abnanb@r.postjobfree.com

Cell - 760-***-****

Home - 760-***-****

A highly efficient, enthusiastic Manufacturing Technician with over 10 years of experience in a manufacturing

environment and the biotech industry. Principal strength include cross-functional communications, working

within a team environment, and multi-tasking with expertise in:

• Aseptic Cleanroom Technique

• Excellent Aseptic gowning history

• Knowledge of cGMP

• Zero Sterility Failure

• Cell Culture Experience

ADVANCED BIOHEALING INC June 2008 - Present

Manufacturing Associate

• Responsible for a wide variety of cell related functions including but not limited to cell expansion; cell

feeding, harvesting, counting, product seeding, labeling, packaging, freezing of product and culture media

preparation

• Responsible for completing Batch Record per SOP for each task performed, cleaning procedures, aseptic

processing techniques, current Good Manufacturing Practices ( cGMP ) and laboratory safety practices and

procedures.

• Performs production related tasks as assigned by the Area Supervisor or Group Lead.

FAVRILLE, INC

Manufacturing Technician IV January 2006 - June 2008

Manufacturing Technician III November 2004 - 2006

• Performs a variety of procedures utilizing proper aseptic technique to produce final product including sterile

filtration, protein conjugation, formulation, aseptic filling of final product, final product labeling, and 100%

visual inspection of final product.

• Played an important role in furnishing and organizing the New Fill Finish Suites and Autoclave Preparation

Area.

• Supported IT and QC in the Operational, Installation, and Process Qualification of new equipment ( Hach

Particle Counter). Received an Employee Peer Award.

• Assisted QC Department in Environmental and Dynamic Monitoring in the execution of Validating the New

Fill Finish Suites. Received a Managers Employee Award.

• Assisted and Executed Process Development Validation Protocols.

• Train manufacturing personnel to implement new process, job procedures, equipment operation and other

phases of their job. Delegate production schedules and tasks. Gives feedback to Supervisor in regards to

Operators job performance.

• Follows, maintains and completes production documentation including Standard Operating Procedure, Batch

Records, and equipment logbook. Ensure timely and accurate generation of process documentation.

Reviewing Master Batch Record.

• Interface with all support groups especially with Quality Control, Quality Assurance, Material Management

and Document Control.

• Assisted Production Support Group in the preparation and formulation of buffers utilized in manufacturing

processes.

• Inventory control of Fill Finish supplies. Responsible for ordering raw materials/supplies ensuring release

before production.

• Successfully lead operators in the execution of 24 Media lots to validate New Fill Suite and New Production

Process.

• Cross-trained in the Cell processing group in harvesting and viral amplification.

• Familiar with InSite EBR (Electronic Batch records ) using CAMSTAR Database..

• Maintaining the cGMP compliance of a Cleanroom work environment.

• Conducts gown training to new employees and related support groups .

CARDINAL HEALTH AND PHARMACEUTICALS

ManufacturingTechnician II May 2004 - November 2004

• Operated Sartorious Sartocheck III Machine and performs filter integrity testing.

• Assisted in filling/capping operations and labeling of product vials.

• Performed 100% visual inspection of unlabeled product vials.

• Familiar with the operation of the Finn-Aqua Autoclave, Kuhlmann Autoclave, Metromatic Vial Washer,

Paxall Stopper Washer, Despatch Dry Heat Oven and the Penn-Tech Vial Washer.

• Performed the preparation and sterilization of fill components.

• Performed the sanitization of class 100 areas.

• Cleaned and Washed Filling components and performed Conductivity testing

INVITROGEN

Product Team Technician II April 2003 - May 2004

4 Performed processes and procedures to maintain inventory of products without supervision.

5 Maintained accurate inventory (i.e. kitting, closing, transfers, returns, expensing) of raw materials, WIP, and

finished product through JDE Edwards Database.

6 Efficient production and quality analysis of reagents, components, and finished products in accordance with

the production schedule.

7 Keep a clear, complete and accurate account of each manufacturing process through Batch Data Records,

work order documents.

8 Familiar with the processes for pre-assembling and assembling standard kits and transferring to

Shipping/Distribution.

7 Understand the general protocol for the preps including set-up, inoculation, harvest, aliquot and QCs such

as contamination, phage testing and performing transformation assays.

8 Experienced in setting up 7L and 15L fermentation vessels ( Applikon and LH) and programming the

controllers.

9 Operated the M & O Perry aliquoting machines in the cold room and transferring cells from dry ice or the

Cryomed freezer to the storage –80 degrees Cent.

STMICROELECTRONICS – San Diego, CA.

Manufacturing Specialist II April 2000 - April 2002

MOLECULAR BIOSYSTEMS, INC. – San Diego, CA. May 1995 - April 2000

Manufacturing Technician II

EDUCATION

B.S. of Business Administration Major in Accounting,

University of the East (UE), Manila, Philippines

Member of the Accounting Honor’s Class

TECHNICAL TRAINING

• Skillpath Seminars

• Microbiology and Safety Training

• Total Quality Management (TQM)

• Participated in Mock and FDA Inspection.

Contact this candidate