Title: Senior Manufacturing Engineer
Department: Operations
Reports to: General Manager
Job Summary:
- Manage facility, utility, and tooling projects.
- Coordinate tooling repairs and improvements.
- Optimize BFS equipment and packaging lines.
- Develop and manage a Preventative Maintenance program.
- Provide technical support for customer follow-up and troubleshooting.
- Participate in CAPEX activities.
Key Responsibilities:
- Manage project pipelines in line with Quality Systems and customer requirements.
- Provide technical support to Manufacturing, QA, Purchasing, and CommOps, including validations and calibrations.
- Develop project plans, manage milestones, and ensure timely completion.
- Support production trials and prepare documentation.
- Contribute to continuous improvement initiatives.
- Interact professionally with all levels of associates.
- Observe safety and security procedures, report unsafe conditions, and use equipment properly.
- Control and minimize environmental impacts, including chemical handling safety.
- Perform physical tasks such as sitting, standing, walking, crouching, using tools, and lifting up to 15 pounds (occasionally up to 100 pounds).
- Undertake other duties as assigned.
Qualifications:
- BA/BS degree with 4-7 years of combined experience in manufacturing, plant/operation, or technical roles, or an equivalent combination of education and experience.
- Extensive knowledge in plastic, medical device, or pharmaceutical processing.
- Understanding of cGMP and FDA requirements for manufacturing.
- Experience with aseptic filling of pharmaceutical products (Blow-Fill-Seal) is a plus.
- Knowledge of automation is a plus.
