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Senior Process Engineer

2 months ago

New York, United States Pfizer Full time
Pfizer Singapore is recruiting permanent employees for manufacturing site expansion of PFIZER ASIA MANUFACTURING PTE LTD (PAMPL) in Singapore.

Why Patients Need You

Our breakthroughs would not make it to the hands of patients without our pharmaceutical new product introduction team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

What You Will Achieve

Working with Pfizer's dynamic engineering team, you will play a critical role in developing and modifying process formulations, methods and controls to meet desired 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 and also to introduce new products to the site. As a process engineer/ senior process engineer, your focus on the job will contribute in achieving project tasks and goals. It is your domain knowledge, commitment, collaboration and dedication that will help us achieve new milestones and patients across the globe.

Your expertise in the manufacturing domain will help in analyzing and designing a sequence of operations, workflow and automation recipes to improve the company's production facilities within regulations and Good Manufacturing Practices and also to introduction new products on site. You will be involved in activities, such as process monitoring, safety, environmental and quality assessments and improvements, validation, and technology transfers. You will also conduct studies pertaining to technical feasibility plans, cost control and reduction, and production record systems. On the basis of these studies, you will develop and implement plans and programs for new production introduction, facility modifications and revisions to operating methods. As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

How You Will Achieve It

  • Develop Manufacturing / Operating Instructions and necessary Standard Operating Procedures.
  • Develop, maintain, review and troubleshoot the process control system recipe / models. Guide process engineer in team for the process control system recipe / models development.
  • Investigate, report and troubleshoot findings on both quality and EHS related issues observed during manufacturing or during batch record review. Participate or lead quality / safety investigations and implement any corrective and preventive actions from these investigations.
  • Develop, implement and monitor robust preventive measures for processing issues.
  • Lead/ part of cross functional team for product transfer of new product on site and interface with above site and transferring sites to ensure flawless transfer of product to site.
  • Able to carry out technical and/or GMP assessment for evaluation of processes.
  • Lead/ part of team for product/ process transfer between the different process centric team for the commercial manufacturing and provide technical guidance to the process centric team and/ or operation team during the manufacturing.
  • Play a pro-active role and lead changes in ensure the site safety and quality standards are adhered to.
  • Proactively monitor, identify, develop and implement improvements in processes and equipment.
  • Communicate on a regular basis to the plant personnel and stakeholders on process updates.
  • Provide operating instruction and process training to different audiences such as operations, process team, quality operations and engineering.
  • Own one or more multiple equipment / GMP systems in production and present the system overview with evidence compliance to internal and external auditors.
  • Train the process technicians on the process and procedures as required.
  • Ensure adherence to approved procedures and update procedures as required, including the principles and practices of good data management (ALCOA)
  • Focus on Safety and GMP Compliance as operational priorities and as performance measures.
  • Accountable for the Good Data Management and Data integrity understanding and performance.
  • Report and investigate actions or behaviors that may negatively impact the desired outcome of the GMP process or activity.
  • Play an active and impactful role to deliver flawless execution for respective PCTs (e.g. API, MS, QO, Leadership, Engineering) by updating performance against metrics, highlighting & resolving issues with appropriate escalations
Qualifications

Must-Have
  • Bachelor's Degree, preferably in Chemical Engineering or degree in science with major in Chemistry
  • At least 5 years' experience in pharmaceutical (API), with relevant manufacturing environment for senior position
  • Good organization skills, attention to detail and proactive.
  • Demonstrated ability to provide technical solutions for complex problems through equipment and process understanding
  • Working knowledge of Food and Drug Administration Regulations, and Good Manufacturing Practices
  • Strong written and verbal communication skills
  • Fully complete Covid-19 vaccination and could provide official medical certificate
Nice-to-Have
  • Master's degree
  • Demonstrated experience in a relevant manufacturing environment
  • Experience in automation including DeltaV and equipment validation
  • Proactive, has experience with high performance teams, strong interpersonal and project management skills

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.

Engineering

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