Validation Engineer

*****

Rosado Ct

ph: 805-***-****

Temecula, CA 92592

Jeff Cordero e-mail:

*********@*****.***

[pic]SPECIALIZED IN

Validation

Manufacturing Equipment, Utilities, Automation

Commissioning, IQ, OQ, PQ, Change Control and Quality Risk Management

PROFESSIONAL EXPERIENCE

Consulting Firm

12/14

- 2/15

Gilead Sciences, Inc, Foster City, California

Validation Engineer

. Responsible for providing QA oversight for equipment validation with a

focus on facility, utilities, and process equipment (API)

qualification, CAPA, deviation and discrepancy resolution.

Consulting Firm

7/13 -

9/13

Baxter Bioscience, Inc. Glendale, California

Validation Engineer

. Responsible for writing cleaning verification protocols for new CIP

skids.

Genentech, Inc. Oceanside, California

11/05 - 7/13

Senior Quality Engineering Validation Specialist

. Responsible for reviewing and approving validation protocols (IQ, OQ,

SIP PQ, cleaning validation PQ and swab studies) engineering documents

(URS, RTM,) for automation (DeltaV and BMS), utilities and

manufacturing equipment in addition to providing technical support and

quality oversight for validation and engineering.

. Additional responsibilities include change control, QC/QA discrepancy

management assessment, quality risk management (PHA/FMEA), periodic

review and annual product review.

. Participate in cross site quality engineering-validation teams to

leverage expertise, increase efficiency and to ensure we achieve a

global harmonized validation program that is quality compliant.

Consulting Firm

05/04 - 11/05

Genentech, Inc. Oceanside, California

Validation Specialist

. Responsible for writing and executing commissioning, IQ, OQ and PQ

protocols for buffer prep, buffer hold, media prep, fermentation,

purification, bulk chemical storage, utilities and CIP systems.

. Additional responsibilities included reviewing system turnover

packages, walking down and redlining P&ID drawings and participating

in SIP PQ cycle development.

Consulting Firm 08/02 -

05/04

Amgen, Inc. West Greenwich, RI

Validation Specialist

. Project Lead responsibilities included scheduling and executing

environmental chamber temperature mapping IOQs for quality analytical

laboratory incubators, refrigerators, freezers, cryogenic baths and

cold rooms.

. Prepared Kaye data spreadsheets and final reports for environmental

chamber IOQs.

Baxter Bioscience, Inc. Thousand Oaks, California

Validation Specialist

. Responsible for writing and reviewing validation risk assessments,

validation master plans and IQ, OQ, and PQs for process equipment and

utilities.

. Performed annual equipment re-qualification for lyophilizers,

autoclaves, depyrogenation ovens and tunnels and process equipment SIP

cycles.

Consulting Firm 11/00 -

07/02

Bayer Pharmaceuticals, Inc. Berkeley, CA

Validation Specialist

. Responsible for writing and executing IQ, OQ, and PQs for HVAC

systems.

. Responsible for writing and executing engineering checkout procedure

for HVAC systems.

3M Pharmaceuticals. Northridge, CA

Validation Specialist

. Responsible for auditing inhalation drug delivery department

procedures, training documentation, and SOP's. Assisted in creating a

revalidation procedure for the IDD manufacturing department.

Wyeth/Immunex, Inc. West Greenwich, RI

Validation Specialist

. Responsible for writing and executing IQ, OQ, and PQ's for process

equipment and utilities.

. Assisted in developing and executing SIP cycle validation for bulk

manufacturing vessels and product transfer lines.

Praxair, Inc. Buffalo, NY

Validation Specialist

. Responsible for writing PQ's for software testing and generating final

report for validation documentation.

Amgen, Inc. Thousand Oaks, California

06/97 - 10/00

Manufacturing Associate II

. Responsible for the preparation of aseptic filling process equipment

and components, operating lyophilizer, aseptic fill machines, and

performing environmental monitoring during filling operations.

. Wrote and executed OQ's for aseptic fill machines and sterile

component hold time.

. Wrote weekly schedule and assigned daily responsibilities to aseptic

filling personnel, reviewed and revised standard operating procedures.

. Assisted in plant start-up operations in Longmont, CO.

. Responsibilities in Longmont included the operation of SCADA

controlled roller bottle filling line, and warm room automated bottle

transfer system.

. Performed preventative maintenance on the roller bottle fill-line and

CIP/SIP skids.

. Performed CIP/SIP of product transfer lines.

. Assisted in executing cleaning validation and SIP PQ's of roller

bottle filling machine and product transfer lines.

Biogen, Inc. Cambridge, Massachusetts

09/93 - 11/95

Process Operator III

. Responsible for the validation of manufacturing equipment and

processes IQ, OQ, SIP PQ and cleaning validation. Wrote and executed

IQ's for formulation vessels during scale up operation.

. Wrote and executed PQ's for autoclaves, depyrogenation oven,

lyophilizer, cold rooms and freezers. Maintained laboratory

notebooks, equipment and metrology lists for the aseptic fill

department.

. Performed small-scale formulation and aseptic filling operations for

clinical trials.

. Responsibilities included, cleaning, sanitization, and environmental

monitoring of production areas.

. Wrote standard operating procedures, document change requests,

critical change orders, and validation protocol final reports.

Paragon Vision Sciences. Phoenix, Arizona

08/91 - 09/93

Compounder, 02/93 - 09/93

. Responsible for automated formulation of sterile products, which

included, weighing of raw materials, CIP/SIP of formulation vessels

and transfer lines.

. Executed PQ's on formulation vessels, executed OQ of formulation

process control system.

Lead Fill-Room Operator, 08/91 - 02/93

. Responsible for plant start-up operations, including, writing standard

operating procedures for the aseptic fill department and assistance in

executing OQ's, and SIP/cleaning validation PQ's on the aseptic fill

machines and product transfer lines.

. Performed fill machine changeover and mechanical adjustments.

. Performed cleaning, and sanitization of the aseptic core.

. Performed CIP/SIP of product transfer lines, and fill machines.

. Responsible for scheduling filling operations.

. Wrote training documentation for fill-room personnel.

. Performed environmental monitoring of aseptic fill operations.

EDUCATION

University of Phoenix

Bachelors of Science, Business/Project Management November-2014

ISPE, Member since 2004.

Contact this candidate