Roche Singapore Technical Operations Pte Ltd

Manufacturing Engineer

Roche Singapore Technical Operations Pte Ltd Date Posted: 25-Oct-2017

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Job Nature:
Permanent
Position Level:
Experienced
Qualification:
Bachelor's / Honours, Masters / PhD

Job Description

Key Responsibilities:
  • Responsible for providing support to manufacturing operations by developing, coordinating and facilitating projects to ensure planned, predictable production operations in compliance with GMP regulations.
  • Lead and execute Continuous Process Improvements, CAPAs, CRs, and TAs in assigned area.
  • Align new improvement ideas according to site’s priorities and capacity.
  • Support inspection work such as presenting during inspections, responding to observations, and driving closure of inspection related Change Records.
  • Support Change Records Assessment and GMP documentation Review.
  • Participate in and lead project teams to deliver business results focused on improving manufacturing business processes to improve reliability, increase simplicity and enable growth.
  • Provide routine and ad hoc support for planning, coordinating, execution, and performance improvement of key manufacturing processes such as product change over.
  • Lead project teams to trouble shoot medium to complex problems and support continuous process improvement. Facilitate root cause analysis (RCA) with input from SMEs, develop and implement change to improve performance.
  • Responsible for Make Assess Release (MAR) matrix generation and compilation.
  • Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors, including inter-organizational impact.
  • Create and maintain training material as needed by the manufacturing to qualify new and existing technicians.
  • Serve as trainer for Area Core Skill Training for Manufacturing new hires.
  • Participate periodically in selected manufacturing floor activities to maintain up to date floor knowledge.

Who you are 
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

Requirements: 
 
Education and Experience
  • BS/BA in Science, Mechanical/Chemical Engineering or a relevant discipline.
  • Fundamental knowledge of Operational Excellence (Six Sigma, LEAN, 5S, etc) principles is a plus.
  • Minimum of 3-5 years work experience (assumes a Bachelor degree) or 2-3 years experience with a Masters (assumes a Bachelor)  in GMP biopharmaceutical production, preferably including project management.

Knowledge, Skills and Abilities
  • Seeking candidates with an in-depth understanding of biopharmaceutical manufacturing process, strong analytical thinking and problem solving skills.
  • Demonstrated track record of taking initiative, resolving complex problems, recommending and implementing process improvement.
  • Must work collaboratively and effectively to foster effective interdepartmental and cross-functional partnerships.
  • Demonstrated ability to manage competing priorities ad allocate, adjust, and optimize assigned department resources.
  • Excellent verbal and written communication skills. Attention to detail and quality oriented
  • Well versed in cGMP with the ability to ensure procedures, processes and systems are optimized and compliant.
  • Ability to work under pressure, assert oneself, fast decision making skills and high flexibility
Appointment to this position will be on local Singapore salary and benefits package.
Key Responsibilities:
  • Responsible for providing support to manufacturing operations by developing, coordinating and facilitating projects to ensure planned, predictable production operations in compliance with GMP regulations.
  • Lead and execute Continuous Process Improvements, CAPAs, CRs, and TAs in assigned area.
  • Align new improvement ideas according to site’s priorities and capacity.
  • Support inspection work such as presenting during inspections, responding to observations, and driving closure of inspection related Change Records.
  • Support Change Records Assessment and GMP documentation Review.
  • Participate in and lead project teams to deliver business results focused on improving manufacturing business processes to improve reliability, increase simplicity and enable growth.
  • Provide routine and ad hoc support for planning, coordinating, execution, and performance improvement of key manufacturing processes such as product change over.
  • Lead project teams to trouble shoot medium to complex problems and support continuous process improvement. Facilitate root cause analysis (RCA) with input from SMEs, develop and implement change to improve performance.
  • Responsible for Make Assess Release (MAR) matrix generation and compilation.
  • Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors, including inter-organizational impact.
  • Create and maintain training material as needed by the manufacturing to qualify new and existing technicians.
  • Serve as trainer for Area Core Skill Training for Manufacturing new hires.
  • Participate periodically in selected manufacturing floor activities to maintain up to date floor knowledge.

Who you are 
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

Requirements: 
 
Education and Experience
  • BS/BA in Science, Mechanical/Chemical Engineering or a relevant discipline.
  • Fundamental knowledge of Operational Excellence (Six Sigma, LEAN, 5S, etc) principles is a plus.
  • Minimum of 3-5 years work experience (assumes a Bachelor degree) or 2-3 years experience with a Masters (assumes a Bachelor)  in GMP biopharmaceutical production, preferably including project management.

Knowledge, Skills and Abilities
  • Seeking candidates with an in-depth understanding of biopharmaceutical manufacturing process, strong analytical thinking and problem solving skills.
  • Demonstrated track record of taking initiative, resolving complex problems, recommending and implementing process improvement.
  • Must work collaboratively and effectively to foster effective interdepartmental and cross-functional partnerships.
  • Demonstrated ability to manage competing priorities ad allocate, adjust, and optimize assigned department resources.
  • Excellent verbal and written communication skills. Attention to detail and quality oriented
  • Well versed in cGMP with the ability to ensure procedures, processes and systems are optimized and compliant.
  • Ability to work under pressure, assert oneself, fast decision making skills and high flexibility
Appointment to this position will be on local Singapore salary and benefits package.

Company Overview

Roche Singapore Technical Operations Pte Ltd
Roche Singapore Technical Operations Pte Ltd
Roche Singapore Technical Operations Roche Singapore Technical Operations is Roche’s first biologics manufacturing site within Asia region, and the first company in Singapore to produce US FDA licensed bio therapeutics using recombinant DNA technologies. Our Vision and Mission We will be the most admired biotechnology production operation, respected for our world class innovation, engrained quality inspired people and operational excellence. Quality is every patient’s right and every employee’s responsibility. Quality provides a competitive advantage and is engrained in everything we do, from concept through continuous improvement. Because Roche’s products touch human lives, quality is the true measure of our success. The Business of Improving Human Lives With over 500 employees, two state-of-the-art facilities, using two different production technology platforms to manufacture bacterial and mammalian cell-based products – all within a 12.6 hectare biomedical space. Here