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

The Capital Engineering Process Engineer is a key technical role responsible for providing engineering and process equipment expertise for the execution of Capital projects at the McPherson site. The role requires a high level of technical expertise in pharmaceutical processing systems, formulation equipment, high purity piping distribution systems, aseptic filling operations, terminal sterilization processes, inspection / packaging equipment, and clean room facilities design requirements. The incumbent will provide focused process ownership and the technical expertise to ensure high quality and efficient sterile injectable products. As technical lead, the Capital Engineering Process Engineer partners with supervision and production colleagues to identify and implement innovative solutions.

This role focuses on developing new processes on site, resolving engineering issues, and providing technical support and troubleshooting during all phases of the Capital project. The Capital Engineering Process Engineer supports the Capital Portfolio Manager in the execution of assigned projects, which may include the coordination of internal company resources and vendors as part of the execution of projects.

How You Will Achieve It

• Act as a technical resource for new manufacturing equipment and processes as part of the Capital Project.

• Complete assigned tasks in adherence with all company and site engineering policies and procedures.

• Provide technical input for cGMP validation, including validation protocols, risk assessments, URS/FDS/FAT/SAT/IQ/OQ/PQ documents and reports.

• Provide technical training on process and equipment as required by Operations.

• Develop and maintain productive links with process equipment & technology suppliers and vendors.

• Represent Engineering on project teams where responsibilities would include SME technical input on the resolution of technical issues or changes arising throughout the Capital project lifecycle whilst ensuring overall project objectives of scope, cost and schedule are adhered to.

• Work to implement a culture of Right-First Time through partnerships with Operations, New Product Introduction teams and Technical Services.

• Anticipate potential process-related problems, risks, and technical conflicts and develop necessary contingency plans that optimize business continuity.

• Complete assigned work activities in strict accordance with safety guidelines and processing standards cGMP’s and SOP’s.

Qualifications

Must-Have

• Bachelor's Degree in Engineering, Science or equivalent with particular emphasis on process, chemical or mechanical disciplines.

• Minimum 1 year relative experience in engineering, pharmaceuticals, manufacturing or a combination of the three.

• Demonstrated ability to provide technical solutions for complex problems through equipment and process understanding.

• Excellent verbal / written communication and interpersonal skills and an ability to work independently.

• Microsoft Applications skills.

Nice-to-Have

• Working knowledge of Food and Drug Administration Regulations, and Good Manufacturing Practices.

• Understanding of Pharma / Bio-pharma process equipment and change management.

• Demonstrated experience in a relevant manufacturing environment.

• Knowledge of the Pfizer Capital Project Management Processes preferred.

PHYSICAL/MENTAL REQUIREMENTS

The position requires a very high level of resourcefulness, an ability to get things done by removing obstacles, perceiving and resolving problems, making difficult decisions with less than complete information provided, and accomplishing project and operational goals through innovative management. Role requires ability to safely navigate construction sites, and project areas.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Travel required for vendor selection, FAT support, and global network meetings; less than 10%
• Off-shift work minimal; project related
• Annual shutdown requires significant site