Job Type
Full-time
Description
JOB OVERVIEW The Manufacturing Engineer I supports manufacturing operations through process optimization, continuous improvement initiatives, troubleshooting and implementation of industrial and automated systems, asset management activities, and compliance driven manufacturing support. This role partners closely with Operations, Quality, Facilities, and other cross-functional teams to improve operational efficiency, product quality, and manufacturing performance. This position reports to the Manufacturing Engineering Manager.
Requirements
JOB DUTIES AND RESPONSIBILITIES - Develop and implement manufacturing process solutions to address operational capability gaps, including optimization of existing equipment and evaluation, specification, or procurement of new equipment as needed.
- Support day-to-day manufacturing operations by troubleshooting manufacturing, industrial, and/or automated equipment issues to minimize downtime and maintain operational efficiency.
- Develop, revise, and maintain Standard Operating Procedures (SOPs), work instructions, process documentation, and engineering records.
- Support continuous improvement initiatives utilizing lean manufacturing, root cause analysis, and data-driven problem-solving methodologies.
- Participate in deviation investigations, CAPA activities, nonconformance reviews, and process improvement projects.
- Collaborate with Mechanical, Process, and Quality Engineering for the creation and execution of validation documents (RTM, CP, IOPQ, etc.) as well as data generation, and report generation.
- Develop and maintain project schedules, status reports, and implementation plans using project management tools.
- Maintain accurate equipment and asset records within the company's asset management system.
- Track equipment lifecycle activities including installation, maintenance history, calibration status, repairs, upgrades, and replacement planning.
- Assist in developing standardized asset management procedures and equipment documentation.
- Support manufacturing readiness activities for new products, process and/or equipment changes, or scale-up initiatives.
- Ensure compliance with GMP requirements, company procedures, and applicable regulatory standards.
- Communicate project status, risks, and timeline impacts to management and key stakeholders.
EDUCATION - Bachelor's degree in Engineering (Manufacturing Engineering, Industrial Engineering, Mechanical Engineering) Life Sciences, or related technical discipline.
- 2 - 4 years of manufacturing or engineering experience preferred.
KNOWLEDGE / SKILLS / EXPERIENCE - Strong understanding of manufacturing processes, industrial equipment, and continuous improvement methodologies.
- Hands-on troubleshooting experience with automated manufacturing equipment and production systems preferred.
- Ability to diagnose and resolve mechanical, electrical, pneumatic, and process related manufacturing issues.
- Familiarity with industrial automation systems, equipment controls, sensors, and manufacturing support systems preferred.
- Understanding of GMP requirements and regulated manufacturing environments preferred.
- Strong analytical and root cause investigation skills with the ability to interpret technical data and develop effective corrective actions.
- Effective verbal and written communication skills.
- Understanding of equipment lifecycle management, preventive maintenance strategies, and equipment reliability concepts.
- Strong communication and cross-functional collaboration skills in a fast-paced manufacturing environment.
Salary Description
$75,000.00 - $88,000.00
