Process Engineer

at  Pfizer

Why Patients Need You
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing 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
Your expertise in the manufacturing domain will help in analyzing and designing a sequence of operations and workflow to improve the company’s production facilities within regulations and Good Manufacturing Practices. You will be involved in activities, such as process and trends monitoring, safety and environmental improvements, process improvements and validation. You will also look at reducing cycle time, lead time and process robustness.

Position Summary

• Will be responsible for leading product manufacturing campaigns from the start of production, and providing technical supervision with respect to quality and EHS until completion and release of the material.
• Contribute to achieve our vision of being the best in class manufacturing site, producing highest quality products in the safest way.
• Deploy and use the IMEx “way of working” for day to day operations, problem solving, escalations and continuous improvements.

Core Competencies

• Technical
• Knowledge
• Communication
• Teamwork
• Team Player
• Management
• Creativity & Innovation
• Self-motivated and independent

Position Responsibilities

• 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 ensuring 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 on process updates
• Train the process technicians on the process and procedures as required.
• Ensure adherence to approved procedures and update the procedures as required, including the principles and practices of good data management (ALCOA)
• Initiate change control and draft adhoc GMP documents
• Focus on Safety and GMP Compliance as operationa丨priorities and as performance measures”
• Account able 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.
• Own on or more multiple equipment/GMP systems in production and present the system overview with evidence compliance to internal and external auditors.
• Develop courses of action and drive implementation of solutions
• Play an active and impactful role to deliver flawless execution for respective PCTs (e.g. API, MS, 00, Leadership, Engineering) by updating performance against metrics, highlighting & resolving issues with appropriate escalations.
• Work with the PCT to identify and drive improvement as per continuous improvement (Cl) goals of the PCT.
• Uphold Pfizer’s code of conduct and values
• Collaborate with cross-functional teams to drive flawless execution. Internal Stakeholder includes:
• Operation - for supporting operation team to meet production targets in cycle time and output
• Supply Chain - for ensuring availability of raw materials for production and supply of finished products to the market, for qualification of alternate source of material/consumables
• Quality - for production batch release and production investigation/improvement
• Engineering - for equipment readiness and production investigation/improvement
• EHS - for performing safety review of changes in the manufacturing processes and in safety related investigation
• Technical Services -for product chemistry, process design understanding, production investigation improvement and product transfer
• External Stakeholders: Equipment Vendors and raw material suppliers - for new materials/equipment/consumables sourcing and during process investigation/improvement

Qualifications

Must-Have

• Degree in Engineering, preferably in Chemical Engineering or Degree in Science
• Demonstrated ability to lead people or processes
• Basic functional and technical knowledge of the discipline
• Good organization skills and attention to detail
• Ability to document clearly and concisely
• Effective written and oral communication
• Knowledge of Microsoft Applications

Nice-to-Have

• Knowledge of Good Manufacturing Practices, Good Documentation Practices
• Experience in Pharmaceutical environment
• 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 team player and communication skills

Work Location Assignment: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Manufacturing

• 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 ensuring 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 on process updates
• Train the process technicians on the process and procedures as required.
• Ensure adherence to approved procedures and update the procedures as required, including the principles and practices of good data management (ALCOA)
• Initiate change control and draft adhoc GMP documents
• Focus on Safety and GMP Compliance as operationa丨priorities and as performance measures”
• Account able 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.
• Own on or more multiple equipment/GMP systems in production and present the system overview with evidence compliance to internal and external auditors.
• Develop courses of action and drive implementation of solutions
• Play an active and impactful role to deliver flawless execution for respective PCTs (e.g. API, MS, 00, Leadership, Engineering) by updating performance against metrics, highlighting & resolving issues with appropriate escalations.
• Work with the PCT to identify and drive improvement as per continuous improvement (Cl) goals of the PCT.
• Uphold Pfizer’s code of conduct and values
• Collaborate with cross-functional teams to drive flawless execution. Internal Stakeholder includes:
• Operation - for supporting operation team to meet production targets in cycle time and output
• Supply Chain - for ensuring availability of raw materials for production and supply of finished products to the market, for qualification of alternate source of material/consumables
• Quality - for production batch release and production investigation/improvement
• Engineering - for equipment readiness and production investigation/improvement
• EHS - for performing safety review of changes in the manufacturing processes and in safety related investigation
• Technical Services -for product chemistry, process design understanding, production investigation improvement and product transfer
• External Stakeholders: Equipment Vendors and raw material suppliers - for new materials/equipment/consumables sourcing and during process investigation/improvemen