Overview
On Site
Full Time
Skills
FOCUS
IT Management
Finance
Regulatory Compliance
Manufacturing Operations
Project Implementation
MBA
Six Sigma
Lean Methodology
GMP
Manufacturing
Collaboration
Project Management
Job Details
Job Description:
- We are seeking a Principal Process Engineer with a strong background in GMP manufacturing and engineering.
- The ideal candidate will have hands-on experience in biologics, process systems, automation, and utilities with a focus on upstream and/or downstream processes.
- The role will be initially remote and then onsite in Wilson , NC, once the facility opens.
- Provide technical leadership in GMP large molecule biologics manufacturing.
- Engineer and modify processes to ensure efficient process start-up and reliable operations.
- Support greenfield and/or brownfield facility start-up including process systems, automation, and utilities.
- Collaborate with cross-functional teams on various projects and drive business solutions.
- Lead or support multiple complex engineering projects simultaneously.
- Synthesize business, technical, and financial information into actionable project plans.
- Ensure compliance with GMP and safety standards in all project phases.
- Bachelor's degree in engineering or a related technical field.
- Minimum 8 years of process/plant engineering experience in GMP biologics manufacturing.
- Experience with upstream and/or downstream manufacturing processes.
- Experience with Delta automation systems.
- Strong background in engineering, manufacturing operations, and project execution.
- Strong collaboration and project leadership skills.
- Master's Degree (MS), MBA, or Ph.D.
- PE (Professional Engineer) certification.
- FPX certification, Six Sigma, or Lean experience.
- Active participation in ISPE and/or ASME BPE.
- GMP Manufacturing experience.
- Engineering background.
- Team collaboration and project leadership.
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