Process Engineer (Changeover)

Why Patients Need You

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, manufacturing is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative manufacturing 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 manufacturing team, you will play a critical role in developing and modifying process formulations, changeover operations, methods and controls to meet desired quality and compliance 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 an associate, your focus on the job will contribute in achieving project tasks, delivery and goals. It is your domain knowledge, commitment, collaboration and dedication that will help us achieve new milestones and patients across the globe.

Roles and Responsibilities

• Responsible for developing changeover cleaning philosophy, cleaning limits, instructions, cleaning flow diagrams and necessary Standard Operating Procedures.
• Developing the changeover cleaning schedule and communication with cross functional departments for close follow up and timely release of equipment for production.
• To investigate, troubleshoot and report findings on both quality and safety related manufacturing issues (e.g changeover cleaning issues (QARs/IRSs).
• To develop, implement and monitor technical solutions for cleaning issues.
• Play a pro-active role in ensuring the site safety standards are adhered to.
• Ensure the changeover cleaning activity meets the agreed site quality standards and compliance of data according to standard operating procedures.
• Ensure the changeover cleaning is actively validated and maintained in validated state.
• Proactively monitor, identify, develop and implement improvements in equipment changeover cleaning to improve the RFT and changeover time.
• Communicate on a regular basis to the plant personnel on cleaning updates.
• Train the process technicians on the equipment changeover cleaning and procedures as required.
• Ensure adherence to our approved procedures and update these as required.
• Collaborate closely with shift team supervisors for adherence to SWP and performance monitoring through visual management.
• Contribute to the completion of project milestones, prioritize and organize own work to meet project task deadlines and communicate progress on scheduled projects.
• Organize testing associated with the development of new process technologies and the support of new product introductions and tech transfers.
• Coordinate all work on scheduled projects (personnel activities, documentation and outside resources).
• Perform other tasks necessary to support site compliance to Center and regulatory requirements.

Qualifications

Must-Have

• Degree in Engineering, preferably in Chemical Engineering or Degree in Science.
• 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 and Documentation Practices
• Proactive, a good team player, strong interpersonal and project management skills
• Strong written and verbal communication skills
• Microsoft Applications skills

Nice-to-Have

• Demonstrated experience in a relevant manufacturing environment
• Knowledge and experience with API and equipment
• Preferably, at least 2-3 years experience in a relevant manufacturing and pharmaceutical environment. Fresh graduates without experience may be considered

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

  
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.