Senior Facilities Engineer, exp in Project Management & Validation

Personal Data

Name : Bogie Destya Manendra

Sex : Male

Place / Date of Birth : Surabaya, 26 December 1978

Nationality : Indonesian

Passport number : R570310 (valid until 14 March 2013)

Status : Married

Qualifications

Capable to work hard and smart both team work or individually.

Able to work under pressure.

Good leadership, analytical skills and problem solving with relevant tools.Design System, Testing and Validation for Sterile Pharmaceutical Process Facilities, Oral Solid Dosage (OSD) and Cephalosporin in compliance with ISO 14644-1, FDA/ EU GMP and ISPE Baseline for Sterile Manufacturing guidelines.

Capable to design Process system for Aseptic areas, Real Time monitoring system and conduct Risk Assessment in compliance with ICH Q9 (Quality Risk Management).

Capable to design Process, Instrumentation & Piping Diagram for Facilities system in accordance with ASME Process Piping & ASME Bio Processing Equipment.

Good understanding on Design and Testing of HVAC System in compliance with ASHRAE, NEBB and SMACNA regulations.

Excellent knowledge on configured, setting and troubleshooting of Real Time Monitoring System.

- Particle Measuring System (PMS) : PharmaNet 3.2 SP1

- Lighthouse Worldwide Solutions : LMS Pharma 7.1.0

Great knowledge of Computer System Validation, inclusive of PLC Validation, SCADA system, Paperless system Validation, CMS Validation in compliance with 21 CFR Part 11 (Electronic Records and Signatures), EU GMP Annex-11 and Good Automated Manufacturing Practices (GAMP4/ 5).

Capable to Designing, Operation and Validation of Purified Water System, Water for Injection and Clean steam in compliance with ISPE Baseline for Pharmaceutical Water & Steam, ISPE Commissioning & Validation and USP.

Good understanding of Validation of Compressed Air & Gaseous, comprise of Solid Particle Contents, Dew Point and Oil Contents/ Vapor in compliance with ISO 8573-1 (Contaminants & Purity Class)

Great knowledge of Validation of Pharmaceutical Water System, conventional water system (Cation-Anion Exchanges), Membrane technology (Single/ Double Pass RO), EDI system, Distillation Plant (Multi-effect Still & Vapor Compression) and Clean steam Generator in compliance with USP & relevant guidelines.

Qualification of Warehouse which inclusive Temperature mapping.

Advance Quality Control Circle Certified.

Computer skilled :

- Windows Application : Microsoft Office (Microsoft Excel, Microsoft Word, Power Point,

Microsoft Project), Lotus Notes, Oracle 11i

- Drawing Application : Visio Drawing, Autocad 2009

- Other Application : Adobe Photoshop

- Internet browsing and E-mail

Training

Environmental Monitoring System/ Real Time Monitoring System Training including operation, application settings (graphical, trending, events, map creation, reporting, alarms, troubleshooting, configuration).

- LMS Pharma V 7.1.0 (Lighthouse Worldwide Solutions).

- PharmaNet 3.2 SP1 (Particle Measuring System/ PMS).

Clean Room Air Management and HVAC Fundamental in Pharmaceutical Industries & Validation Practices.

Environmental Monitoring & Particle Counter in Pharmaceutical Industries.

Pharmaceutical Water System Training on RO membrane and Distillation Plant including operation, maintenance and troubleshooting.

Membrane Technology System.

Instruments calibration and settings (ALNOR, HACH ULTRA, METLER TOLEDO, KAYE VALIDATOR).

ORACLE 11i and Advance Supply Chain Planner (ASCP) ORACLE Training including application programming, operation, configuration settings, transaction flow, reporting, etc).

Risk Management in Pharmaceutical Industries.

Advance QCC Training and Certification.

SUMMARY

Strong in Technical knowledge of Facilities system which inclusive of HVAC, Purification Water, Distillation system, BMS/ CMS/ EMS system, Compressed Dry Air and Gaseous system.

Excellence experience in the Facilities Project Management Design, Control, Costing, Testing, Commissioning and Validation in compliance with relevant guidelines.

Great experience in Managing Project from Designing, Document preparation, Tendering, Selections (negotiations and gap analysis) until awarded and system fully tested handed over to the user (upon completion of Test & Commissioning and Validation).

Experience

KOTRA PHARMA (M) SDN BHD (www.kotrapharma.com)

is Good Manufacturing Practices (GMP) Standard Certified, PIC/s certified and ISO 9001:2008 system accredited by United Kingdom Accreditation Services (UKAS)

Product Ranges: Generic & Injectables Products for Cephalosporin and Non-Cephalosporin

June 2008 to Present

Designation as Senior Facility Engineer

Supervise maintenance staff dedicated to Facilities Department (HVAC, Water System, CMS/ BMS/ EMS, Compressed Dry Air, Gaseous, Fire Protection, Lift System, WWTP)

Lead and coordinate Facilities Project for New Building expansion which inclusive of Mechanical & Electrical Services; starting from preparing URS Conduct Tender, selections and awarded, Preparing Design Qualification upon receiving Functional and Design Specification, execute FAT and SAT with suppliers and assisting Test & Commissioning which execute by awarded supplier.

Prepare protocol for Validation and Lead the Validation (IQ/ OQ/ PQ) executions for entire Facilities system and closely involving on New Plant certification/ Audit by authority.

Budget preparation and spare part control for cost effective planning.

Do monitoring (old plant and New Plant Operations) to ensure smooth day running production and diligent inspection of entire Facilities system for any abnormalities which may occur interruption.

Do troubleshooting in the events of system breakdown and upgrade technician skill by conduct regular training on pertaining required item.

Ensure the requirements of quality and operations (e.g. ISO9001, GMP and GLP); Occupational Safety and Health, and Environment System Control are met.

Serve as liaison between the company and the various governmental agencies and contractors and clients (internal) on all maintenance projects

Regular monitoring for system performance and Preventive Maintenance program. Directly Reporting to Facilities Manager and General Manager-Plant.

PT. PYRIDAM FARMA, Tbk (www.pyridam.com)

is Good Manufacturing Practices (GMP) Standard Certified, Go Public Pharmaceutical company with ISO 9001: 2008 system accredited by SGS.

Product Ranges: Health care Supplements & Generic Beta Lactam and Non-Beta Lactam.

March 2007 to May 2008

Designation : Power Maintenance Supervisor

Supervise maintenance staff dedicated to Power & Maintenance Department (HVAC, Water System, Compressed Dry Air, Lift System, WWTP, Production machines).

Closely involving for Equipment and New machines transferring, installation, set-up and conduct Test & Commissioning.

Preparing documents/ protocol for Validation (IQ/ OQ/ PQ) for equipment/ new machines transferring.

Do troubleshooting in the events of system breakdown and upgrade technician skill by conduct regular training on pertaining required item.

Budget preparation and spare part control for cost effective planning.

Work with QA and QC dept to ensure supporting utilities are in a state of compliance to all regulatory requirements.

Regular monitoring for system performance and Preventive Maintenance program. Directly Reporting to General Manager-Plant.

PT. MEIJI INDONESIAN (www.meiji.co.id)

is Good Manufacturing Practices (GMP) Standard Certified, subsidiary of Meiji Seika Kaisha Ltd Japan, Certified by Pharmaceutical Manufacturing Development Agency (PMDA) Japan.

Product Ranges: Sterile Injectables Products, Oral Solid Dosages form and Semi Solid Preparation (Beta Lactam and Non-Beta Lactam).

January 2005 to March 2007

Designation : Engineering Development & PM Control Assistant Section Head

Supervise maintenance staff dedicated to Maintenance & Utilities Section (HVAC, Water System, Compressed Dry Air, WWTP, Electrical and Production machines).

Prepare Master Annual Preventive Maintenance schedule and monitor the executions.

Prepare protocol and design for any project improvements/ development.

Troubleshooting in the events of system breakdown and upgrade technician skill by conduct regular training on pertaining required item.

Work with QA and QC dept to ensure supporting utilities are in a state of compliance to all regulatory requirements.

Preparing documents/ protocol for Validation (IQ/ OQ/ PQ) for equipment/ new machines transferring.

Budget preparation and spare part control for cost effective planning.

Participate and responsible for Fire Protection System, and as a Safety and Health Committee ensure is compliance to the safety standards.

Directly Reporting to Plant Director.

PT. MARGA BUMI MATRA RAYA

is Surabaya-Gresik Toll Highway Corporation.

March 2004 to January 2005

Designation : Ahli Teknik Satu (Information System Department)

Do routine check for Electrical Toll Devices (PC, Printer, Barrier, PED, ITT, etc) regularly for all toll gates.

Conduct Troubleshooting for any abnormality on the system (Hardware and Software).

Prepare jig and tester for Integrated Toll Terminal (ITT) In Circuit Test (ICT) and Functional test(FT).

Simulation on proto type design of ITT system, perform debug and test for ITT.

Managed and monitor team on production of ITT.

Responsible and reporting to Information System Manager.

PT. TEC INDONESIA

is ISO 9001:2000 system accredited by United Kingdom Accreditation Services (UKAS) and ISO 14001:2000 accredited by DQS, subsidiary of TOSHIBA TEC Singapore Pte Ltd and TOSHIBA TEC Japan Ltd.

Product : Sub-Assembly (Motherboard, Sub-card, RAM) and Full Assembly for IBM Product (Laptop, LCD Panel, Desktop PC), Lexmark Printer, TOSHIBA LCD Panel, Cash Register and Load Cell.

Nov’ 2001 to Nov’ 2003

Designation : Manufacturing Supervisor1

Supervise, guide and motivate team (Operators, Leaders, technicians and Ass. Supervisor) to achieved productivity, smoothly shipping and mainline requirements as per latest DPSS schedule and lead time.

Maintain Inventory accuracy in compliance with ORACLE database.

Ensure all production process as per Process Control Plan (PCP).

Coordinating with Maintenance Team to improve machine performance, reduce down time machine and Line Balancing.

Conduct machine Programming for New Product on SMT, AI, AOI and BGA machines.

Modification of machine software for Line Balancing, improve machine cycle time and Yield.

Closely involving with ORACLE Singapore during designing of New Project for Advance Supply Chain Planner (ASCP-Jupiter) ORACLE for PT. TEC INDONESIA.

Configuration, Setting and Troubleshooting for any matter arise on ORACLE system.

Coordinating Team to conduct periodically Preventive Maintenance.

Responsible and reporting to Manufacturing Senior Manager.

PT. MATSUSHITA KOTOBUKI ELECTRONIC PERIPHERAL INDONESIA (PT. MKPI)

is ISO 9001:2000 system accredited by United Kingdom Accreditation Services (UKAS) and ISO 14001:2000 accredited by DQS, subsidiary of Panasonic Corporation Japan.

Product : HDD Maxtor

Dec’ 2000 to Sept’ 2001

Designation : Technical Specialist

To lead team to conduct routine checks on all Auto, Semi Auto and Manual Bonding machines.

Perform inspection, modification and testing on all machines and equipments.

Monitor process production, improve yield and reduce machine downtime.

Simulate jig and datum sizing and monitoring defects through Gage R&R.

Software and hardware (jig) modification for Quality Improvement and reduce COPQ.

Coordinating team to conduct regular Preventive Maintenance.

Responsible and reporting to Manufacturing Manager.

CAREER SYNOPSIS – Bogie Destya Manendra

Bogie Destya Manendra has a great background and understanding in Facilities Project Management which has been proven handle and managing several project which concurrently executed. Total project costs approximate min USD 4.7 million. Closely involving on project starting Design, Costing, Testing, Commissioning and Validation in compliance with relevant guidelines.

Great experience in Managing Project from Document preparation, Tendering, Selections (negotiations and gap analysis) until awarded and system fully tested handed over to the user (upon completion of Test & Commissioning and Validation).

Bogie Destya Manendra has wide experience in the facilities process, Real Time Monitoring System, Clean room manufacturing process & Clean room Validation in compliance with relevant guidelines.

Bogie Destya Manendra is married, with no children presently, working and living in Malaysia and communicates fluently in English.

Bogie Destya Manendra has excellence knowledge in Pharmaceutical guidelines and compliance for Facilities Project Management, Operations and Validation as well.

Project Management Experience

Pharmaceutical Water System (PW/ WFI/ CS) Contract Sum : EUR 1,970,000.00

STILMAS SpA

Clean Room Monitoring System

Contract Sum : USD 179,000.00

Lighthouse Worldwide Solutions

Compressor & Ring Distribution System Contract Sum : MYR 1,992,800.00

Airserv Engineering Sdn Bhd

HVAC System Contract Sum : MYR 11,728,000.00

New Malaysia Sdn Bhd

Nitrogen Gaseous Contract Sum : MYR 600,000.00

JJK Engineering Sdn Bhd

Professional Certification

Cert no : 00/092/126/X/2000

National Occupational Skilled Certificate - Balai Latihan Kerja Indonesia 2000

Senior Electrical Technica

Cert no : 12/BLK-SBY/855.10/1645/VIII/1999

National Occupational Skilled Certificate - Balai Latihan Kerja Indonesia 1999

Power Installation Level3

Achievement

GOLD AWARD Winner for Project Presentation on Quality Control Circle Lean Waste/ Cost Reduction

PT. MATSUHITA KOTOBUKI ELECTRONIC PERIPHERAL INDONESIA (PT. MKPI)

ORACLE SYSTEM DATA ACCURACY (OSDA) Lean Waste/ Increase Inventory Accuracy

PT. TEC INDONESIA

Education

Sepuluh Nopember Institute of Technology Surabaya - Indonesia 1997 - 2000

Industrial Electrical Enginering

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