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Lead Process Engineer

2022-03-04 14:33:392025-06-27Daksta
Job Type Permanent
Location Raleigh, North Carolina, USA
Area USA, USA Raleigh, North Carolina, USA
Market Life SciencesLife Sciences - ConstructionLife Sciences - Engineering
Salary $110,000 - $140,000 USD
Currency GBP
Start Date
Advertiser Courtney Robb
Job Ref MG-265
Description
Daksta are partnered with a global EPCMV leader within the Life Sciences  market who are working on the countries largest and technologically advanced Life Sciences  facilities and require a Lead Process Engineer in Raleigh, North Carolina, USA 

The Process Engineer V - BLS is responsible for leading a system design team on Biopharma Life Science (BLS) projects. Systems will include product production, primary and secondary manufacturing, packaging, and distribution  upstream and downstream biologics manufacturing, small molecule synthesis, fill/finish, and specialty chemicals, and high purity water, waste treatment, and clean and support utilities.

Responsibilities:


  • Works with or leads a team of engineers and/or designers to create and document designs fulfilling the project design scope consistent with industry-accepted practice as well as client-preferred standards, with minimal supervision
  • Develops system design from Concept Phase through Construction Documents
  • Supports FAT/SAT inspections as required
  • Responsible for quality control, cGMP compliance, and approval of concepts, basis of design, process flow diagrams, process and instrumentation diagrams, piping and equipment plans, details, specifications, cost, and schedule for all Process Systems
  • Contributes to the Process Knowledge Center via documenting lessons learned, completing CIP assignments from regional system expert, and use of information developed by others in process discipline
  • Supports the Proposal Manager, Design Manager and Construction Manager with Fee Development Guide, change orders, quality assurance, scheduling, staffing, progress report outs, interdisciplinary coordination, and other responsibilities as agreed to by the project lead and/or Discipline Director
  • Works as a Task Force Lead coordinating with Regional System Experts and project leads to identify and develop system specific standard tools (drawings, specifications, checklists, calculators) for lean project execution, promoting project to project repeatability and consistency across ATF/BLS segments
  • Mentors and trains junior staff
 
Expertise Required

  • Bachelor’s degree in Chemical Engineering, Biomanufacturing, or related field required
  • Professional Engineer (PE) License preferred
  • Nation Council of Examiners for Engineering and Surveying (NCEES) Record preferred
  • 10+ years of experience
  • Experience in all phases of BLS manufacturing; Clinical, Development, Commercial
  • Prior experience with innovative and advanced technology such as single-use, continuous manufacturing, and ATMP-based platforms 
  • Proven track record of cGMP-focused design deliverables
  • Experience in leading teams and workgroups, small to medium, on BLS projects
  • Prior experience in consulting engineering
  • Experience working within a team environment
  • Experience in the quality control and compliance review process
  • Experience in Design Qualification development and execution
  • Experience in cGMP, HAZOP and OSHA design reviews
  • Experience in managing third party design resources
  • Experience in FDA-focused risk management
  • Experience in BIM/3D design platforms
  • Experience in Hygenic design
  • Experience contributing to continuous improvement processes
  • Detailed understanding of all core Process Systems used in BLS projects
  • Detailed knowledge and understanding of industry codes and standards applicable for their process system design and specifications
  • Detailed understating of Lean execution principles for design of projects
  • Detailed knowledge of current Good Manufacturing Practices (cGMP) guidance as issued by FDA
  • Good time management skills, strong work ethic and attention to details
  • Good verbal and written communication skills
  • Must be a strong team player with an ability to build effective working relationships with individuals, department leads, and client representatives
  • Ability to train team on cGMP design and lean principles needed to design and manage project
  • Ability to mentor and train junior staff
 
  • $110,000 - $140,000 USD
Apply
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