Thursday, 14 April 2011

Company Confidential - Principle/Senior/Process Engineer


Based in Batam - Various Positions-Principle/Senior/Process Engineer - Injection Molding Process 

MNC is a global leader in the research, development and manufacturing of contact lenses. With its expansion in Asia Pacific manufacturing facilities located in Batam, Johor and Singapore, is now seeking for highly qualified and motivated individuals who are willing to take challenging roles in our Engineering and Quality Team to support the growing Asian Supply Chain business.

We invite suitable candidates to apply for these positions. These positions will be based in Batam, Indonesia.


1.     Principle / Senior / Process Engineer  - Injection Molding Process
Job Responsibilities:
  • Analyze all issues related to molding processes, develop optimal solutions and lead implementation.
  • Understand & analyze process issues in contact lens manufacturing and improve existing level of manufacturing and automation for reliability and output.
  • Work with R&D, production, quality, maintenance functions to ensure quality production at lowest possible cost.
  • Responsible for technical support and continuous process improvement in various developmental projects and in manufacturing.
  • Understand the impact of process and/or automation and lens handling on the final product quality.
  • Provide technical support for manufacturing operations including troubleshooting, investigating and resolving process, product, project, automation and control issues.
  • Diagnose and solve plastic parts molding production quality problems using effective problem solving techniques.
  • Troubleshoot and develop efficient molding processes, while working on existing equipment to optimize throughput and quality while minimizing scrap and downtime.
  • Generate accurate equipment set-up and operating instructions and train molding technicians in molding processing and set-up techniques.
  • Provide technical expertise for tool changes and cycle time reductions.
  • Responsible for fixture development, line and plant layout
  • Identify & record the problems related to Process & initiating actions to provide solution.
  • Maintain daily production reports as per ISO Standards.

Job Requirements:
  • Bachelor in Engineering/Diploma.in Mechanical/Industrial Engineering or Diploma in Plastic Engineering or candidate from experienced in plastics injection molding.
  • Minimum 3 to 5 years of experience in Engineering Plastic components/contact lens/precision electronics manufacturing Industry.
  • Candidate should preferably have knowledge of Maintenance in Injection molding machines.
  • Hands-on experience in processing of Engineering Plastics and should have good hands on experience in Molding Machines and Machine Parameter setting.
  • Basic Knowledge in Tools & Die / Mold maintenance including knowledge and working understanding of tool construction.
  • Candidate must be conversant of ISO-9001 system.
  • Knowledge of Plastic processing materials viz. PP, SAN, ABS, PC, PS, etc required.
  • Awareness of quality standards required for processing different polymers and well versed with Molding defects.
  • Hands-on experience in process engineering using process improvement tools (DOE, FMEA). Good understanding of safety practices.
  • Strong problem solving, analytical, communication and interpersonal skills.
  • Knowledge of AutoCAD or Solidworks will be advantage.
  • Candidate familiar with GMP working environment or with Six Sigma certification will be added advantage.

2.     Principle / Senior / Process Engineer  - Automation & Process Controls
Job Responsibilities:
  • Analyze all issues related to automation and control, develop optimal solutions and lead implementation.
  • Understand & analyze process automation issues in contact lens manufacturing and Improve existing level of automation for reliability and output.
  • Work with R&D, production, quality, maintenance functions to ensure quality production at lowest possible cost.
  • Responsible for technical support and continuous improvement of automation systems in various developmental projects and in manufacturing.
  • Responsible for developing various automation projects scope, schedule, cost, implementation plan and user requirement specifications with input from all stake holders and to ensure design meets the Quality and other business requirements (DQ).
  • Understand the impact of automation and lens handling on the final product quality.
  • Provide technical support for manufacturing operations including troubleshooting, investigating and resolving automation issues.

Job Requirements:
  • A qualification or equivalent of Bachelor in Engineering/Mechatronics/ Electrical/Mechanical or Computer Engineering.
  • Minimum of 5 years industry related experience in PC based controlled machines, instrumentation, vision system, control & automation at the design and implementation level.
  • Proven experience in PLC programming with any of the following PLCs: Allen Bradley, Modicon, Keyence, GE Fanuc, Siemens, Mitsubishi, Omron, etc. 
  • Able to program and configure HMI or SCADA of any of the following software packages from Wonderware, Rockwell Automation, Siemens, etc.
  • Must be able to create and read logic and flow diagrams for program design, programming, simulation and testing, and start-up.
  • Ability to develop and implement standard engineering practices, as well as provide detailed documentation upon project completion.
  • Minimum 3 years mechanical design experience using CAD softwares such as AutoCAD, Solidworks, Pro E, etc.
  • Setting up servo drive systems (Allen Bradley, Yaskawa, etc.) experience.
  • Hands on experience with electro-mechanical troubleshooting in a high-volume automated manufacturing environment.
  • Excellent oral and written communication skills.


3.     Principle / Senior / Process Engineer  - Color Specialist
Job Responsibilities:
  • Establish and maintain an efficient production process and system.
  • Provide process improvement & re-engineering for product yield & quality improvement.
  • Provide technical specifications necessary to control the production process.
  • Investigate the process and quality failure and provide solution to correct them.
  • Carry out the change request and evaluate the change affects on validation process.
  • Manage and execute engineering study protocol which includes data collection and analysis.
  • Support process, equipment and technology transfer & implementation.
  • Provide or facilitate technical training for the relevant personnel.
  • Support other department on major technical trouble-shooting.

Job Requirements:
  • A qualification or equivalent of Bachelor in Engineering.
  • Minimum of 5 years working experience in manufacturing plant, preferably in pharmaceutical/medical device.
  • Knowledge in industrial equipment, process controls and troubleshooting.
  • Ability to develop and implement standard engineering practices, as well as provide detailed documentation upon project completion.
  • Good project management
  • Excellent oral and written communication skills.

4.     Compliance Manager
Job Responsibilities:
  • Manage and facilitate the Quality Management System implementation, standardization and adherence within MNC Batam manufacturing in accordance to cGMPs, legal, ISO, regulatory requirements as well as MNC and Novartis Quality Manual requirements.

  • Develop, implement and maintain batch record review and release process, annual product review, quality management review, CAPA, nonconformance management and local complaint processes for MNC Batam manufacturing.

  • Provide follow-up to all non-conformances, ensuring development of actions plans to address issues preventing reoccurrence. This is inclusive of an effectiveness verification process following implementation of corrective and preventative actions.

  • Develop, implement and maintain the internal audit program.  Perform internal audits per an established schedule ensuring all quality systems are checked on an annual basis.

  • Develop, implement and maintain the supplier audit program.  This includes the coordination and/or performance of external audits. The position could include a minimum of 10% travel.

  • Assist in hosting Regulatory inspections. Responsible for ensuring all observations are appropriately addressed and compliance review initiated.
  • Review audit readiness strategy and oversee preparedness for regulatory bodies inspections by managing field CAPA's, any regulatory actions, follow ups, and assisting in product problem resolution

  • Responsible for Quality metrics and establishment of follow-up actions as required to maintain metrics within appropriate parameters.

  • Responsible for the improvement process associated with the quality systems to ensure review on a periodic basis continually increasing compliance as well as staying current or ahead of industry trends.

  • Responsible for staying aware of the FDA database and website with respect to industry changes, challenges and regulatory trends.

  • Responsible for the review of validation and process changes in manufacturing to ensure compliance with standards and submissions.

  • Responsible for the GMP and technical training programs to ensure they incorporate the required modules to sustain compliance.

  • Responsible for ensuring Data Integrity is maintained through routine audits of quality systems.

  • Provide leadership, direction and support to the people within the QA departments and ensure they are qualified, achieve a high level of competence, are motivated and carry out their duties in a safe and effective manner.

  • Work with the Quality Staff to ensure quality plans are being maintained.

Job Requirements:
  • Bachelor in Engineering or Physical Sciences/Chemistry/Physics or its equivalent other appropriate education and experience in medical devices or pharmaceuticals.
  • Minimum of 5 to 7 years Quality Management experience in pharmaceutical/medical device/health care environment.
  • Experience in Quality Control, Quality Assurance and Compliance or Regulatory Affairs.

  • Knowledge in change control, statistical process control, training systems and manufacturing process. 

  • Proven knowledge in cGMPs/Regulatory Affairs/Validation/Laboratory, 21CFR820 and ISO 13485 requirements.
  • Excellent oral and written communication skills.

5.     Supplier Quality Engineer
Job Responsibilities:
  • Develop, implement and maintain the supplier audit program. Ensure that supplier audits are conducted as per an established schedule.

  • Assist in supplier audit and follow through the audit report and response from supplier or users.

  • Responsible for ensuring all suppliers are categorized as per global SOPs.

  • Responsible for conducting periodic supplier performance monitoring as per schedule and plan.

  • Responsible for supplier management training programs for staff.

  • Responsible for ensuring Data Integrity is maintained through routine audits of quality systems.


Job Requirements:
  • Bachelor in Engineering or Physical Sciences/Chemistry/Physics or its equivalent other appropriate education and experience in medical devices or pharmaceuticals.
  • Minimum of 3 to 5 years Quality Management experience in pharmaceutical/medical device/health care environment.
  • Experience in Quality Control, Quality Assurance and Compliance or Regulatory Affairs.

  • Knowledge in change control, statistical process control, training systems and manufacturing process. 

  • Proven knowledge in cGMPs/Regulatory Affairs/Validation/Laboratory, 21CFR820 and ISO 13485 requirements.

  • Excellent oral and written communication skills.

6.     Principle Engineer  - e-Laboratory
Job Responsibilities:
  • Manage and facilitate the Quality Management System implementation, standardization and adherence within Lab. operation in accordance to cGMPs, legal, ISO, regulatory requirements as well as MNC and Novartis Quality Manual requirements.

  • Review laboratory testing OOS SOPs, failure investigation, and OOS record review and testing process status, CAPA, non-conformance management for MNC Batam manufacturing.

  • Develop, implement and maintain the internal audit program for laboratory.  Perform internal audits for laboratories per an established schedule ensuring all quality systems and controls for laboratory.

  • Assist in hosting Regulatory inspections. Responsible for ensuring all observations are appropriately addressed and compliance review initiated.

  • Responsible for the laboratory adherence associated with laboratories computerized system. Regularly review and audit the laboratory system.

  • Responsible for the review of validation and process changes in of laboratories system to ensure compliance with standards and submissions.
  • Responsible for the GMP and technical training programs for laboratories to ensure they incorporate the required modules to sustain compliance

  • Responsible for ensuring Data Integrity is maintained through routine audits of quality systems.

  • Work with the Laboratory Staff to ensure quality plans are being maintained.

Job Requirements:
  • Bachelor in Engineering or Physical Sciences/Chemistry/Physics.
  • Minimum of 5 years Quality Management experience in pharmaceutical/medical device/health care environment.
  • Experience in Quality Control, Quality Assurance and Compliance or Regulatory Affairs.

  • Knowledge in change control, statistical process control, training systems and manufacturing process. 

  • Proven knowledge in cGMPs/Regulatory Affairs/Validation/Laboratory, 21CFR820 and ISO 13485 requirements.

Excellent oral and written communication skills.

An attractive salary will be commensurate with qualification and experience. Foreigners are welcome. All your information would be kept strictly P&C.


Title: Based in Batam - Various Positions-Principle/Senior/Process Engineer - Injection Molding Process
Job Location: Singapore
Job Ref code: MR - Va
Job Category: Manufacturing/ Engineering/ R&D
Key Skills: See JD
Industry: • Electronics Manufacturing • Pharmaceuticals • Semiconductor Manufacturing

 

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