Manufacturing Engineer I

Job description

  Job facts

This position has overall accountability for efficient support of manufacturing in providing GMP compliant systems, processes and the execution of GMP training of personnel.

Key Responsibilities:

·  Comply with all RSTO's Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
·  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.
·  Participate periodically in selected manufacturing floor activities to maintain up to date floor knowledge.
·  As system administrator for manufacturing IPC testing equipment which role and responsibilities includes but not limited to:
·  Maintain users' access control
·  Perform Periodic Review
·  Act as the Discrepancy Owner by:
·  Issue, assess as needed and follow up on assessments
·  Performing Recurring Discrepancy Assessment
·  Summarizing the deviation
·  Initiate/Own Tracking Actions as needed.

Qualifications

·  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 2 years of work experience in cGMP biopharmaceutical production, preferably including project management.
·  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 problems, recommending and implementing process improvement.
·  Must work collaboratively and effectively to foster effective interdepartmental and cross-functional partnerships.
·  Demonstrated ability to lead and drive improvement initiatives.
·  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.

Roche is an equal opportunity employer.
Manufacturing, Manufacturing > Production Engineering

·  Who we are

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer.