Senior Manufacturing Engineer: Lean, NPI & Process Validation

Katalyst CRO; Stamford (CT); On-site; USD 110,000 - 160,000; Full time

Job summary

Katalyst CRO in Stamford, CT seeks a Senior Manufacturing Engineer to optimize production processes, validate equipment, and lead cross‑functional projects in a regulated environment. You will drive continuous improvement, support NPI, and ensure compliance with GMP/cGMP and ISO standards.

The role requires hands‑on process validation, PFMEA/Control Plans experience, and strong analytical and communication skills. You will mentor junior engineers and support audits across QA, R&D, and operations.

Qualifications

• Bachelor's degree in Mechanical, Manufacturing, Industrial, Biomedical, Electrical, Chemical Engineering, or related discipline.
• 58+ years of manufacturing engineering experience in a regulated manufacturing environment.
• Strong knowledge of manufacturing processes, process optimization, and production support.
• Experience with Lean Manufacturing, Six Sigma, Kaizen, and Continuous Improvement.
• Hands‑on experience with process validation (IQ/OQ/PQ), equipment qualification, and manufacturing documentation.
• Experience with CAPA, Root Cause Analysis, PFMEA, Control Plans, SPC, and GD&T.
• Proficiency with ERP/MRP systems and Microsoft Office applications.
• Excellent analytical, problem‑solving, and communication skills.
• Ability to lead cross‑functional projects and manage multiple priorities.

Responsibilities

• Develop, optimize, and maintain manufacturing processes to improve efficiency, quality, and productivity.
• Lead manufacturing projects from concept through implementation, ensuring timely delivery and cost-effectiveness.
• Support New Product Introduction (NPI) by developing manufacturing methods, tooling, and work instructions.
• Design and implement process improvements using Lean Manufacturing and Six Sigma methodologies.
• Analyze manufacturing data to identify process improvements and reduce waste.
• Troubleshoot production issues and implement effective CAPA.
• Develop and execute process validation protocols, including IQ, OQ, and PQ, as required.
• Collaborate with Quality, R&D, Supply Chain, Maintenance, and Operations teams to resolve manufacturing challenges.
• Create and maintain manufacturing documentation, including SOPs, work instructions, process flow diagrams, PFMEA, and control plans.
• Support equipment selection, installation, commissioning, and qualification.
• Participate in design reviews to ensure products are manufacturable and meet quality requirements.
• Lead root cause investigations using 8D, 5 Whys, and Fishbone Analysis.
• Ensure compliance with GMP/cGMP, FDA, ISO 9001, ISO 13485, or other applicable industry standards.
• Mentor junior engineers and provide technical guidance to manufacturing teams.
• Support internal, customer, and regulatory audits.

Skills

Lean Manufacturing

Six Sigma

Kaizen

CAPA

Root Cause Analysis

Process optimization

GMP/cGMP knowledge

ERP/MRP systems

Problem solving

Cross-functional leadership

Education

Bachelor's degree in Mechanical Engineering

Tools

ERP/MRP systems

Microsoft Office

Job description

Katalyst CRO in Stamford, CT seeks a Senior Manufacturing Engineer to optimize production processes, validate equipment, and lead cross‑functional projects in a regulated environment. You will drive continuous improvement, support NPI, and ensure compliance with GMP/cGMP and ISO standards.

The role requires hands‑on process validation, PFMEA/Control Plans experience, and strong analytical and communication skills. You will mentor junior engineers and support audits across QA, R&D, and operations.