Job Description
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POSITION SUMMARY:
The Maintenance Lead position is responsible for supporting manufacturing processes and facilities at Argentum Medical’s campus in Geneva, IL.
The Maintenance Lead primarily executes or supervises maintenance activities related to production and facility equipment, instrumentation, and structures. This includes integrating new or existing processes/equipment and supporting ongoing production through optimal equipment performance. The role also involves calibration activities for critical process equipment and instrumentation as designated by Argentum’s QMS.
This position reports to the Director of Engineering and is a key member of the Engineering and Operations team, collaborating across departments including Operations, Engineering, and Quality & Regulatory Affairs (QRA). It also supports the VP of Operations and Plant Manager regarding process performance.
ESSENTIAL FUNCTIONS (ACCOUNTABILITIES/RESPONSIBILITIES):
1. Execute, coordinate, and document maintenance and calibration activities for production processes, ensuring safety and professionalism.
2. Follow best practices, manufacturer instructions, QMS, and applicable codes/ordinances.
3. Troubleshoot and repair manufacturing and facility equipment/instrumentation in break-fix scenarios.
4. Manage maintenance consumables and coordinate with purchasing on shortages.
5. Develop and improve maintenance and calibration instructions and records.
6. Participate in Argentum’s Safety Program to promote a safe work environment.
7. Assist in equipment commissioning, including FAT, SAT, and process validations (IQ, OQ, PQ).
8. Support Quality & Regulatory Affairs with technical expertise during audits, CAPA, non-conformance, and training.
9. Coordinate with suppliers on maintenance and improvement activities.
10. Conduct regular site inspections to ensure safety and optimal performance.
11. Perform other duties as assigned.
QUALIFICATIONS:
Experience
Minimum of 5 years in a regulated industry (aerospace, medical device, pharma) related to process and equipment maintenance, integration, training, or process improvement. Proven ability to work collaboratively. Knowledge of 21 CFR 820 and ISO 13485 is a plus but not required.
Education
High school diploma, technical certificates relevant to the role, and professional certifications (e.g., Lean Six Sigma) are preferred but not mandatory.
Skills/Competencies
* Effective communication at all levels.
* Strong interpersonal skills for working with co-workers and suppliers.
* Presentation skills for small group settings.
* Initiative and independent work ability, with good judgment.
* Problem-solving skills using logical analysis.
* Sound decision-making based on experience and analysis.
* Adaptability to change and learning.
* Trustworthiness and integrity.
* Teamwork and collaboration skills.
* Moderate proficiency with Microsoft Office and willingness to learn software tools like QT9.
TRAVEL REQUIREMENTS/WORK ENVIRONMENT:
Travel up to 10% may be required.
Work environments include medical device production areas, cleanrooms, storage warehouses, maintenance areas, and typical office settings. Physical demands include lifting up to 40 pounds, with accommodations provided as necessary.
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