19 Apr, 2022

Lead Process Engineer

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

Job Description

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 Lead Process Engineer is expected to serve as SME for core operational areas, which may include focus on sterilization, commodity preparation and formulation operations or Automated Visual Inspection processes and packaging operations, for a dynamic, 24/7 manufacturing operations. Identifies, supports and/or manages projects executed by multiple functions including planning and scheduling all activities to achieve the desired results. Develops and manages project scopes for contractors and consultants in the support of project and process implementation. Leads in the development of project schedules and coordinate applicable work to meet the deadlines in the Plant Capital Plan, New Product Introductions, and New Process Technology Developments. Ensures all project documentation is generated per the schedule, executed on time and that it is complete and accurate. Leads the development of new processes and optimization of existing ones. Supports Data Integrity (DI) initiatives and maintenance of DI compliance associated with manufacturing processes and controls.

 

How You Will Achieve It

  • Acts as the SME for critical process operations within sterilization, commodity preparation and formulation operations or AVI finishing / packaging operators. Expected to have strong process/mechanical/controls knowledge of key process equipment to include formulation systems, CIP/SIP skids, commodity washers, and/or sterilization processes, or labelers, cartoners, bundlers, vision systems, automated visual inspection, leak detection and serialization equipment
  • 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. Person will be 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. Will direct the work of other process engineers and contract engineering resources, to include performance evaluations for Pfizer direct reports.
  • Will be expected to establish methods for ongoing monitoring/trending of process/mechanical issues. Will be 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 Engineering or Technical Science with 5+ years of pharmaceutical manufacturing engineering experience, to include hands-on technical application/knowledge of manufacturing equipment/processes required
    OR
  • Master’s Degree in Engineering or Technical Science with 3+ years of pharmaceutical manufacturing engineering experience, to include hands-on technical application/knowledge of manufacturing equipment/processes  required
  • Knowledge/understanding of global regulations for drugs
  • Knowledge/understanding of CQV strategies
  • Understanding of mechanical design, electro mechanical, and automation controls
  • Excellent communication and presentation skills and attention to details
  • Strong technical writing and presentation skills

 

OTHER INFORMATION

  • Eligible for Relocation Package

 

 

 

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.


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