05 Jul, 2022

Senior Process Engineer

  • Pfizer
  • Rocky Mount, NC, USA
Process Engineer Biochemicals / Pharmaceuticals

Job Description

Why Patients Need You

At Pfizer, our mission is to inspire a best-in-class culture of continuous improvement and project management that empowers colleagues and enables simple, effective processes. Whether you are managing projects or liaising with others, your contribution in this team will help in making our work easier and faster so that we can deliver breakthroughs that change patients' lives.

 

What You Will Achieve

The Sr. Process Engineer is primarily responsible for executing projects planned by Process Engineering. This individual ensures all Process Engineering documentation deliverables are generated, and may be asked to develop new processes or optimize existing ones. This individual may lead large scale projects; as well as, coordinate all work including but not limited to coordination of personnel activities, documentation and outside resources. The Sr. Process Engineer will develop and manage project scopes for contractors and consultants in the support of project and process implementation.
The Sr. Process Engineer supports manufacturing processes and operations at the Rocky Mount, NC facility. Work includes but is not limited to supporting identification and implementation of process improvements, system design, capital project support, and investigation support. Individual ensures all Process Engineering documentation deliverables are generated, is expected to develop new processes and/or optimize existing ones. This individual may lead large scale projects; as well as, coordinate all work including but not limited to coordination of personnel activities, documentation and outside resources. The Sr. Process Engineer will be required to develop and manage project scopes for contractors and consultants in the support of project and process implementation. 
The Sr. Process Engineer is expected to support a broad range of equipment and processes. Employee will be working within a sterile injectable facility, which may include working within clean rooms. Equipment and processes may include packaging/automated visual inspection processes, Formulation systems, CIP/SIP skids, commodity prep, washing, filling, capping and/or sterilization (to include dry heat ovens/tunnels and autoclaves) processes for a broad range of products and product configurations. Engineer will be expected to work with corresponding teams (automation, maintenance, ops, validation, quality functions) at the site to understand, implement and improve processes. Engineer is expected to understand the overall process sequences beyond individual equipment and impact on product quality.

 

How You Will Achieve It

  • SME for critical process operations within formulation and filling operations
  • Expected to have strong process/mechanical/controls knowledge of key process equipment to include commodity washers, dehydrogenation tunnels, autoclaves, fillers, cappers, vision systems, CIP/SIP processes and formulation systems such as mixing tanks.
  • Individual must have project management skills, knowledge and application experience of technical design reviews, commissioning and validation for pharmaceutical processes.
  • Individual will be expected to work routinely with cross functional groups throughout the site for process improvements and implementation.
  • Must have a solid understanding and knowledge of pharma regulations and cGMP principals and demonstrated ability to apply knowledge to process improvements and changes. Responsible for interfacing with auditors and presenting on site processes.
  • Responsible for leading and/or supporting root cause analysis and developing engineering resolutions for corrective actions.
  • Troubleshoots production related equipment/process issues.
  • Organizes, oversees and analyzes testing associated with the development of new process technologies and the support of new product introductions and tech transfers.
  • Works closely with Corporate R&D and technical services to develop and confirm Critical and Key Process Parameters equipment and processes to ensure acceptable quality.
  • Plans, reviews and approves engineering studies for engineering cycle development and research. Leads FAT (factory acceptance testing) and ensures protocol execution is per plan.
  • Supports installation, operational, and performance qualification activities. Direct the work of other process engineers and contract engineering resources, to include performance evaluations for Pfizer direct reports.
  • Expected to establish methods for ongoing monitoring/trending of process/mechanical issues. Responsible for review and approval of site documents to include calibration reports, batch records, SOP’s, change control, and design specs.

 

Qualifications

Must-Have

  • Bachelor’s Degree in an Engineering or related discipline with a minimum of 3 years of engineering experience is required

  • Understanding of mechanical design, electro mechanical, and automation controls

  • Excellent communication and presentation skills and attention to details

  • Strong technical writing and presentation skills

 

Nice-to-Have

  • Pharmaceutical industry and GMP experience is preferred

  • Knowledge/understanding of global regulations for drugs is preferred.

 
 

PHYSICAL/MENTAL REQUIREMENTS

- Able to stand for extended hours for test runs and performance monitoring of processes – will include working within special gowning for area access
- Able to climb ladders/steps
- Able to lift items of 25lbs
- Capable of data analysis using statistical tools/graphing
- Strategic thinker for issue resolution

 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

 

Pfizer operates 24/7 across most of the business units. Employee must have the ability to work extended hours, holidays and/or weekends as needed. Limited travel may be required to support OEM equipment design reviews and/or Factory Acceptance Testing of new equipment.


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