Sr. Manufacturing Engineer

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

Job Description

We are seeking a highly motivated Senior Manufacturing Engineer to support and optimize manufacturing operations by developing robust production processes, improving product quality, and driving continuous improvement initiatives. The ideal candidate will collaborate with cross-functional teams to implement manufacturing solutions, support new product introductions (NPI), validate equipment and processes, and ensure compliance with quality and regulatory requirements.

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 corrective and preventive actions (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 methodologies such as 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.

Requirements

• Bachelor's degree in Mechanical, Manufacturing, Industrial, Biomedical, Electrical, Chemical Engineering, or a 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.