Senior Manufacturing Support Engineer

2 months ago

Singapur, Singapore 825 Glaxo Wellcome Manufacturing Pte Ltd Full time
Job Summary

We are seeking a highly skilled and experienced Manufacturing Support Engineer to join our MSAT Manufacturing Support team at 825 Glaxo Wellcome Manufacturing Pte Ltd. As a key member of our team, you will be responsible for driving commercial manufacturing processes improvements and providing technical expertise in various process disciplines.

Key Responsibilities
  • Manage technical deviations and CAPAs.
  • Manage investigations and troubleshooting of process and equipment issues.
  • Subject Matter Expert (SME) for technical equipment and conduct relevant training.
  • Quality and business-continuity risks. Ensure necessary risk assessments are performed to justify or identify necessary mitigation plans.
  • Performs Gap analysis and follow up of QMS, Quality alerts and VSOPs.
  • Preparing documents as required to support the activities of the operations department.
  • Provide technical leadership and lead root cause analysis sessions in support of quality deviations, equipment/systems issues, and incident reporting and implement appropriate corrective and preventive actions to prevent recurrence.
  • Participate in technical team for discrepancy and investigation resolution, equipment and process validation activities and training on new process technologies.
  • Lead/Support change controls (CC) and implementation to process equipment or the associated manufacturing processes and systems, provides training to the team on these changes.
  • Partner with production team to meet the production schedule, ensure commercial supply, uphold quality standards, and drive towards zero defects.
  • Design processes to optimize efficient process flow, reduce process or product variability, reduce defects, improve process capability, uphold quality standards, and improve employee safety.
  • Perform changes/updates to manufacturing processes and work with manufacturing, engineering, other MSAT teams and QA validation to implement those changes.
  • Review/provide feedback and technical/scientific support on project deliverables, i.e., remediation initiatives, value creation projects (VCPs), technological advancements, strategic site priority projects (SSPs), etc.
  • Establish experimental protocols, conduct experiments, analyse results, and document the information which can be an input to the investigation, CAPA, risk, change control or continuous improvement.
  • Work closely with MSAT Product Stewardship team to identify and confirm critical process parameters needed for equipment and process validation.
Requirements
  • BS or higher degree in Chemical Engineering, Mechanical Engineering, Manufacturing Engineering, Biotechnology, or related Life Science is required.
  • Demonstrated skill and knowledge with analytical methods, equipment, process, software, cleaning, and facility/utility validation strategies and policy, protocol and report writing and execution.
  • At least 4-5 years' experience in Engineering, pharmaceutical industry or equivalent education preferred.
  • Experience in Ultrafiltration/diafiltration systems is preferred.
  • Knowledge of other downstream purification process (e.g. Chromatography) or upstream process (e.g. Fermentation) will add value
  • Familiar with global regulations validation/qualification requirements.
  • Equipment and process troubleshooting skills
  • Knowledge in equipment used in vaccines manufacturing processes.
  • Experience with quality and process improvement methodologies and tools (Lean, Six Sigma, value stream mapping, FMEAs, DMAIC) is desired.
  • Experience with product/process development and project management is a plus.
  • Lean Sigma/ Green Belt certification is a plus.
  • Highly effective communication, facilitation, negotiation, and teamwork skills are required.
  • Excellent interpersonal, written, and verbal communication skills.
  • Adaptable to fast-paced, dynamic work environment with shifting demand.
  • Continuous improvement mindset.

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