Main Tasks & Responsibilities:



Infrastructure Maintenance:

Ensure the professional maintenance of all infrastructure and production systems to guarantee smooth operations. 

Troubleshooting:

Analyze and resolve issues with mechanical and electrical components to minimize downtime. 

System Testing:

Conduct and support system tests (FAT, SAT, IQ, OQ, PQ). 

System Commissioning:

Conduct commissioning of production systems and re-qualification of existing systems. 

Preventative Maintenance and Calibration Planning:

Plan, conduct, and evaluate the preventative maintenance and calibration of various production and facility equipment. 

Qualification Reports:

Generate qualification reports (QR). 

Documentation:

Record maintenance and repair activities and perform administrative tasks to ensure traceability. 

Quality Monitoring:

Report deviations and potential quality issues to the supervisor. 

Efficient Work Practices:

Strive for diligent and efficient work practices. 

Equipment Qualification:

Plan, conduct, and evaluate the qualification of equipment (production machines, measuring devices, tools, and regulated environment rooms) in the medical technology 

Lifecycle Documentation:

Create and train on various lifecycle documents (SOPs). 

Administrative Tasks:

Perform general administrative tasks in the ERP and QM systems. 

Process Compliance:

Ensure compliance with required process standards to maintain inspection readiness. 

Process and SOP Updates:

Continuously update processes and SOPs.  Work overtime as needed (staying later during the weekdays or at least one weekend day per month) Additional responsibilities may include: 

Process Optimization:

Assist in optimizing work processes by recommending improvements. 2/2 

Technical Modifications:

Assess risks of technical modifications and approve their implementation. 

Deviation and Change Control:

Prepare deviation reports and change control requests, and address corrective and preventive actions (CAPA).

Preferred Knowledge, Skill, and Abilities:



Knowledge of Facility Equipmet:

o Compressors o Vacuum pumps o High Purity Water system o Chillers  Knowledge of Packaging Equipment o Pouch Sealing o Blister Sealing o Rinsing equipment  Knowledge of basic computer software o Microsoft Teams o Microsoft Office (Word, Excel) o

Adobe Acrobat Job Type:

Full-time Pay:

$30.00 - $35.00 per hour

Benefits:

401(k) matching Dental insurance Health insurance Paid time off Vision insurance

Education:

High school or equivalent (Preferred)

Experience:

Maintenance:

5 years (Required)

GMP:

2 years (Preferred)

Work Location:

In person