02 Apr, 2024

Process Engineer/ Senior Process Engineer (FMEA)

  • Pfizer
  • Tuas, Singapore
Process Engineer Biochemicals / Pharmaceuticals

Job Description

Why Patients Need You

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.

 

What You Will Achieve

Working with Pfizer’s dynamic engineering team, you will play a critical role in developing and modifying process, methods and controls to meet quality standards. Your production engineering skills will help in recommending and implementing improvements, modifications or additions that will help in solving problems. You will review product requirements in terms of product development compatibility and help Pfizer determine optimum costs and schedules of production.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team.  Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.

 

How You Will Achieve It

Process Engineering

  • Develop Manufacturing / Operating Instructions and necessary Standard Operating Procedures.
  • Develop, maintain and troubleshoot the process control system recipe / models.
  • Investigate, report and troubleshoot findings on both quality and EHS related issues observed during manufacturing or during batch record review.
  • Develop, implement and monitor extensive preventive measures for processing issues.
  • Play a pro-active role in ensure the site safety and quality standars are adhered to.
  • Proactively monitor, identify, develop and implement improvements in processes and equipment.
  • Communicate on a regular basis to the plant personnel on process updates.
  • Train the process technicians on the process and procedures as required.
  • Own one or more multiple equipment / GMP systems in production and present the system overview with evidence compliance to internal and external auditors.

 

Flawless Technical Transfer

  • Familiar with quality control testing and process assessment, and FMEA facilitation techniques.
  • Responsible for maintaining the FMEA program for new product introduction to site and develop results to effectively manage project uncertainty
  • Responsible for lead the FMEA team through the project to an effective conclusion. Implementing a process to create true closure. Providing detailed minutes and specific follow-up plans.
  • Responsible for developing a FMEA assessment to effective completion with associated risk reduced to an acceptable level. Ensure New Product Introduction (NPI) technical transfer team stays on a agreed timeline.

 

Knowledge Management

  • Responsible for working with NPI value stream on uploading knowledge captured from analytical and process robustness studies into Process Understanding Plan (PUP) and facilitating product handover from NPI value stream to Process Centric Teams for commercial manufacturing campaigns.

 

Qualifications

 

Must-Have

  • Bachelor's Degree
  • 2-5 years of experience
  • Knowledge of Good Manufacturing Practices and experience in Pharmaceutical environment
  • FMEA facilitation techniques
  • Broad knowledge of theory and principles within a professional discipline or advanced knowledge of specific technical/operational practices
  • Strong technical, management and organizational skills
  • Good leadership and communication skills

 

Nice-to-Have

  • Master's degree
  • Relevant pharmaceutical experience
  • Experience in automation including DeltaV and equipment validation
  • Knowledge of the manufacturing process and equipment

  
Work Location Assignment: On Premise

 

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


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