Overview
On Site
Full Time
Skills
Requirements Engineering
GMP
Manufacturing
UPS
Manufacturing Engineering
FOCUS
Operational Excellence
MBA
Six Sigma
Lean Methodology
Analytical Skill
Problem Solving
Conflict Resolution
Finance
Manufacturing Operations
Communication
Collaboration
Job Details
Responsibilities:
- Lead or support multiple projects simultaneously, ensuring timely and effective execution.
- Define technical or scientific direction for programs comprising multiple complex projects.
- Engineer new processes and modify existing ones to ensure right-first-time process start-up.
- Collaborate with cross-functional teams to synthesize business needs, manufacturing requirements, engineering elements, and technology inputs into actionable solutions.
- Provide expertise in process systems, automation, utilities, and operations for greenfield or brownfield GMP manufacturing facilities.
- Demonstrate strong analytical skills to evaluate and optimize processes and operations.
- Drive program execution and ensure successful outcomes, meeting technical and operational objectives.
- Bachelor's degree (or equivalent) in Engineering or a related field.
- Minimum of 8 years of experience in process/plant engineering within GMP manufacturing, focusing on large molecule biologics facilities.
- Hands-on experience with GMP manufacturing facility start-ups, including process systems, utilities, and operations.
- Strong technical background in process and manufacturing engineering, with a focus on operational excellence.
- Proven ability to work across multiple projects and lead initiatives with measurable outcomes.
- Advanced degrees such as MS, MBA, or Ph.D. in a relevant field.
- Professional Engineering (PE) certification.
- FPX certification, Six Sigma, and/or Lean experience.
- Active participation in professional organizations like ISPE or adherence to ASME BPE standards.
- Strong analytical and problem-solving skills.
- Comprehensive understanding of financial fundamentals in manufacturing operations.
- Excellent communication and collaboration skills.
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