Engineer Manager

Romulo M. Patungan

***** ******** **. ******* ** 94536 • Home: 510-***-**** • Mobile: 510-***-****

Email: **********@*****.***

Objective:

Engineering Associate or Validation Engineer position within a growth oriented biotechnology or pharmaceutical company.

Summary:

Has various Pharmaceutical and Biotech QC, QA and Engineering experience for 8 years. Involved in several projects in computer, process and equipment validations, revalidations and change control. Experience in installation, calibration and troubleshooting of process control instrumentation.

Strong teamwork, analytical and project management skills. Detail oriented with the ability to perform multiple tasks and manage timelines. Proven efficiency in working with inter-departmental, vendors, contractors and multifunctional teams.

Completed SRA clearance (Botox Immunization-CDC, FBI biometrics, and USCIS) requirements select agent controlled environments.

Validation Experience with:

Finn Aqua ( 699 , 91212-N-D-C-BPS-AB) autoclave

Getinge autoclave

BBraun 50L Fermentor

ABEC 150L Fermentor

Waters HPLC

Spectramax 340pc Microplate Spectrophotometer

Gemini XPS Spectrofluorometer

BioRad Densitometer

Biotek ELX 405 Microplate Washer

Sorvall Centrifuge

RODI system

Clean Steam/ Nitrogen/HVAC/Compressed Air Systems

VWR Low Temperature Freezers

Revco Refrigerators, Freezers, Cold Box and Ultra Freezer with LN2 backup

VWR Liquid Nitrogen Freezers

Sanyo Incubator

Lindberg /Blue Oven

ESI Stability Chambers

Yokogawa DR230 Chart Recorder

Biosafety Cabinets (Class I and II)

Warehouse/ Walk In Cold Storage Chambers

SIP

CIP/COP( classroom trained)

Instrumentation/Metrology Experience with:

Analytical Equipments

Utilities Instrumentation (RO/DI, Compressed Air, Nitrogen, Chart Recorder, BAS/BMS, HVAC, Fermentor)

Equipment Instrumentation (Refrigerator, Freezers, Cold Rooms, Stability Chambers)

Operation of Standards (Validator 2000, Hart, Heise, Vaisala, Druck, Fluke, Contec)

Other Experiences:

SOP writing

Database Management( CalMan, Maximo)

Professional Experience:

ValidPath

Validation Engineer

Sep 2010 to present

• Validation (Revance, Biorad)

- Performance Qualification of Finn Aqua Autoclave

- Cycle Development for Dry Goods Cycle (Finn Aqua)

- Performance Qualification of ABEC 150L Fermentor, generate final report

- VWR Low Temp Freezers (IQ,OQ,PQ, final report)

• Engineering Support (Biorad)

- Improve Equipment Calibration/Maintenance Documentation

- Revise Maintenance SOPs

- Generate Engineering Turn Over Package/Commissioning Package

- Completion of Change Control document

Solstice Neurosciences

Senior Engineering Technician/ Validation Engineer

Oct 2008 to Aug 2010

• Validation

- Responsible for the Annual revalidation (Performance Qualification) of Autoclaves

- Responsible for the Annual requalification (SIP) of BBraun Fermentor

- Author Validation protocols, Validation Amendments, Validation Deviation Reports,

- Responsible for commissioning and IOPQ of Analytical Laboratory equipment, Stability Chambers, Warehouse and other storage equipments,

- Preventive Maintenance of Validation Equipments,

- Responds to Validation Internal Audit.

• Instrumentation/Metrology

- Supervise Solstice Calibration Program

- Administrator for Calibration Database( Blue Mountain Calibration Manager 3.0)

- Directs calibration activities of vendors during annual and semi-annual shutdown.

- Perform onsite calibrations, documents and reviews calibration documentation,

- Initiates Out of Tolerance , Metrology Response Reports,

- Responds to instrument owner service requests,

- Corresponds with service providers for maintenance and calibration contracts,

- Generate monthly calibration due, pastdue, tech audit, and decommissioning, ICR reports.

- Responds to Calibration Internal Audit.

Crumbs Engineering Inc. - July 2002 to Oct 2008

Project Engineer

- Generate, execute and completion of Change Control/test plan.

- Validation of Analytical Instruments

- Project lead for the site wide renaming of equipments. Identification and update of equipment master records,

- Performed IOQ of facility systems( Compressed Gas, HVAC),

- Performed IOQ of facility storage equipments,

- Performed calibration of instruments, directs calibration activities of outside vendors,

- Writing, revising and reviewing of SOPs.

- Author Validation Protocols (URS,IQ,OQ,PQ and Final Report)

Technical Skills

• Proficient in Microsoft Office

• Proficient in Validator 2000 Validation System

• Knowledge in Data Acquisition Systems setup, configuration and calibration

• Calibration Manager 3.0, 4.1 user

• Maximo user

Education/Training

• Bachelor of Science in Medical Technology, 1985 (US Equivalent)

Immaculate Conception College – Davao City, Philippines

• Validation Training, BSTC

• Customer Maintenance Training for Finn-Aqua GMP Sterilizer 699

• Agilent 1100/1200 Series HPLC Routine Maintenance Training (Course# H4058A)

• Validator 2000 ver.3.5 training

• Course QIMT-1400, 21hrs.(Measurement Uncertainty Analysis)

References:

John Boutell

Associate Director, Facilities and Engineering

Solstice Neurosciences, LLC.

701 Gateway Blvd. South San Francisco 94080

Desk: 650-***-****

Direct: 650-***-****

Scott Rutherford

QA Manager

Bio-Rad

12945 Alcosta Blvd, San Ramon, CA 94583

Tel: 925-***-****

Leticia Sim

Manager

Computer Systems/ Instrumentation Validation

Bayer Corporation

820 Parker St, Berkeley, CA

Tel: 510-***-****

Contact this candidate