Katalyst CRO
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Responsibilities
The Process Engineer reports to the Manufacturing Unit Technical Leader and is responsible for driving engineering process improvements, capital equipment upgrades, efficiency gains, and cost reduction initiatives.
The role supports troubleshooting, equipment design improvements, vendor coordination, and provides technical leadership for continuous improvement and production optimization.
Lead and support capital equipment projects, including design, installation, testing, and validation.
Troubleshoot mechanical, pneumatic, cam-driven, and hydraulic systems.
Develop engineering specifications, drawings, and calculations.
Support plant operations by identifying issues and implementing corrective actions.
Manage projects of moderate to large scope, including vendor selection and oversight.
Prepare capital expenditure requests; track budgets and timelines.
Ensure compliance with safety standards and regulatory requirements.
Maintain documentation including SOPs, change notifications, validation documents, PM schedules, and spare parts lists.
Provide training and direction to internal support personnel.
Drive efficiency, quality improvement, waste reduction, and process improvement initiatives.
Coordinate with R&D, vendors, maintenance, and production teams.
Evaluate in-house versus outsourced fabrication options.
Qualifications / Education & Experience
Bachelor's degree in Mechanical, Chemical, or Bioengineering preferred.
All experience levels considered; compensation aligned with experience.
Strong mechanical design and troubleshooting skills.
Hands‑on experience with manufacturing equipment and capital project execution.
Ability to manage multiple projects simultaneously.
Understanding of engineering safety and compliance standards.
Preferred experience in medical device or other regulated manufacturing environments.
Experience with cam-driven equipment, pneumatic, and hydraulic systems.
Experience with equipment validation and documentation.
Vendor and contractor management experience.
Background in cost reduction and process improvement initiatives.
Seniority level
Entry level
Employment type
Full-time
Job function
Management and Manufacturing
Industries
Civil Engineering
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Responsibilities
The Process Engineer reports to the Manufacturing Unit Technical Leader and is responsible for driving engineering process improvements, capital equipment upgrades, efficiency gains, and cost reduction initiatives.
The role supports troubleshooting, equipment design improvements, vendor coordination, and provides technical leadership for continuous improvement and production optimization.
Lead and support capital equipment projects, including design, installation, testing, and validation.
Troubleshoot mechanical, pneumatic, cam-driven, and hydraulic systems.
Develop engineering specifications, drawings, and calculations.
Support plant operations by identifying issues and implementing corrective actions.
Manage projects of moderate to large scope, including vendor selection and oversight.
Prepare capital expenditure requests; track budgets and timelines.
Ensure compliance with safety standards and regulatory requirements.
Maintain documentation including SOPs, change notifications, validation documents, PM schedules, and spare parts lists.
Provide training and direction to internal support personnel.
Drive efficiency, quality improvement, waste reduction, and process improvement initiatives.
Coordinate with R&D, vendors, maintenance, and production teams.
Evaluate in-house versus outsourced fabrication options.
Qualifications / Education & Experience
Bachelor's degree in Mechanical, Chemical, or Bioengineering preferred.
All experience levels considered; compensation aligned with experience.
Strong mechanical design and troubleshooting skills.
Hands‑on experience with manufacturing equipment and capital project execution.
Ability to manage multiple projects simultaneously.
Understanding of engineering safety and compliance standards.
Preferred experience in medical device or other regulated manufacturing environments.
Experience with cam-driven equipment, pneumatic, and hydraulic systems.
Experience with equipment validation and documentation.
Vendor and contractor management experience.
Background in cost reduction and process improvement initiatives.
Seniority level
Entry level
Employment type
Full-time
Job function
Management and Manufacturing
Industries
Civil Engineering
#J-18808-Ljbffr