Engineer 4 - Process

Job Title: Senior/Principal Engineer – Large Molecule Drug Substance (LMDS)
Location: Wilson, NC
Duration: 24+ Months
Pay Rate: $68/hr – $71.50/hr
Travel: Domestic travel most likely once a year

Position Summary:

• Support deployment of the MTO aspiration “to innovate to safely supply quality products and services competitively, faster, always”
• Provide advanced engineering design and start-up support for GMP large molecule biologics manufacturing facility systems and equipment
• Provide integrated equipment, utility, and facility engineering expertise with an operational focus to support technology transfer and manufacturing projects
• Support “right first time” execution and start-up
• Drive innovative solutions in engineering support and process technology
• Coordinate with Technical Operations to ensure alignment with technology standards and engineering specifications

Key Responsibilities:

• Work extensively with external partners (A&E firms, construction firms, equipment vendors) to develop, organize, and execute project plans as SME and process systems owner
• Demonstrate strong understanding of GMPs and regulatory requirements
• Serve as Process Engineering Expert for business-based technology solutions
• Support execution of strategic and key CAPEX manufacturing projects
• Drive “right first time” start-up and execution
• Provide technical leadership for technology transfers and new technology development projects
• Ensure process fit to plant methodology and practices
• Understand manufacturing challenges and translate business needs into engineering solutions
• Lead multi-functional teams on projects and process improvements
• Resolve inter-functional issues
• Collaborate with manufacturing, quality, and engineering teams to define project priorities
• Support recruiting project team members
• Demonstrate communication, leadership, conflict management, and risk management skills

Education:

• Bachelor’s degree in Chemical Engineering or Mechanical Engineering required
• MS / MBA / PhD / PE Certificate preferred

Required Experience:

• Minimum 8+ years of process/plant engineering experience in GMP manufacturing large molecule biologics facilities
• Experience in greenfield or brownfield GMP manufacturing facility start-up
• Experience with process systems, automation, utilities, facilities, and operations

Required Skills:

• Strong technical background in process engineering
• Strong technical background in manufacturing engineering
• Strong analytical skills

Top 3 Non-Negotiable Skills:

• Drug substance equipment design
• Start-up activities
• FAT