Lead Process Engineer

  Apply  

Irfa******

  • United States 
  • Last Update: 03.05.2019 at 12:00

Job Type
Full Time
Start
ASAP
Duration
6 Month +
Place
Rocky Mount, North Carolina
Country
United States

Category


Regulatory, Quality and Clinical

Description


ROLE RESPONSIBILITIES
  • Acts as the SME for critical process operations within TS/Aseptic formulation and filling operations. Expected to have strong process/mechanical/controls knowledge of key process equipment to include formulation systems, CIP/SIP skids, commodity washers, liquid filling, capping equipment/vision systems, RABS/Isolators, and/or sterilization processes. 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. 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.
BASIC QUALIFICATIONS
  • Bachelor's Degree in Engineering, Technical Science, or similar with 5+ years of pharmaceutical manufacturing engineering experience, to include hands-on technical application/knowledge of manufacturing equipment/processes is 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
PHYSICAL/MENTAL REQUIREMENTS
  • Able to stand for extended hours for test runs and performance monitoring of processes - will include working within special gowning for cleanroom 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

Get In Touch