Responsibilities:
- Responsible for automated equipment performance in the Parenteral area; provide first-line support to production processes.
- Support area engineering initiatives, process improvements, and project implementation.
- Develop expertise in production processes, commissioning, qualification, and validation requirements, and equipment-specific code/control system technologies.
- Ensure equipment is maintained in a qualified state and can be operated safely; maintenance is properly performed on systems (maintenance activities are not in the scope of this position).
Key objectives/deliverables:
- Ensure operational/maintenance procedures reflect safety concerns; perform activities per cGMPs and applicable procedures.
- Use equipment performance data to identify quality improvement opportunities.
- Communicate with all levels to plan/coordinate projects and repairs with minimal disruption.
- With the process team (engineers/operations), participate in and sometimes lead development of equipment design, procedures, engineering studies, and maintenance practices.
- Improve equipment operational effectiveness and reliability.
- Provide technical support to engineering, including investigating/resolving issues causing production delays; transferring knowledge to operators/engineering/maintenance; implementing learning tools; contractor/vendor coordination; creating maintenance action plans as needed; participating in periodic equipment-state reviews; plan/execute small process/equipment improvement projects.
Minimum requirements:
- Associateβs Degree (or equivalent work experience).
- Legally authorized to work in the United States; no anticipated visa sponsorship (e.g., H-1B/TN).
Preferred qualifications/skills:
- Experience in a GMP manufacturing environment.
- Safe work practices in a participative environment.
- Experience with highly automated equipment.
- Instrumentation; PLC and/or HMI programming; Studio 5000 and FactoryTalk View SE.
- Proficiency with Microsoft Word and Excel; able to type and write technical documents.
- Independent work, strong organization, attention to detail, and ability to adapt to changing priorities.
- Strong interpersonal and communication skills; customer service attitude.
- Knowledge of Parenteral equipment and manufacturing operations.
- Experience with Maximo or similar computerized maintenance management system.
- B&R platform experience (plus).
Additional information:
- 3-2-2 Shift Schedule.