Key Responsibilities:

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 Commissioning: Conduct commissioning of production systems and re-qualification of existing systems.

·        Documentation: Record maintenance and repair activities and perform administrative tasks to ensure traceability.

·        Process Optimization: Assist in optimizing work processes by recommending improvements.

·        Quality Monitoring: Report deviations and potential quality issues to the supervisor.

·        Efficient Work Practices: Strive for diligent and efficient work practices.

·        Project Involvement: Support investment projects through procurement and implementation phases.

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

·        Design Verification: Review design specifications and conduct design qualifications (DQ).

·        Risk Analysis: Create technical risk analyses.

·        Qualification Plans: Develop qualification plans (QP) and traceability matrices (TM).

·        System Testing: Conduct and support system tests (FAT, SAT, IQ, OQ, PQ).

·        Qualification Reports: Generate qualification reports (QR).

·        Computer System Validation: Plan, conduct, and evaluate computer system validations in the medical technology

·        Customer and Auditor Interaction: Represent qualification projects to customers and external auditors.

·        Document Reviews and Requalification: Plan and conduct document reviews, requalification's, and functional checks.

·        Calibration Planning: Plan, conduct, and evaluate the calibration of measuring devices.

·        Technical Modifications: Assess risks of technical modifications and approve their implementation.

·        Lifecycle Documentation: Create and train on various lifecycle documents (SOPs).

·        Deviation and Change Control: Prepare deviation reports and change control requests, and address corrective and preventive actions (CAPA).

·        Project Implementation (Engineering CP Medial): Responsible for the efficient and qualitative implementation of new projects and engineering tasks through defined processes.

·        Bill of Materials and Operations Plans: Capture and adjust bills of materials and operations plans.

·        Article Specifications: Create and define article specifications and maintain the article database. Provide information for the creation of material specifications.

·        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) 

Preferred Knowledge, Skill, and Abilities: 

·        Knowledge of Facility Equipment:

o   Compressors (Mattei)

o   Vacuum pumps (Busch)

o   High Purity Water system (BTW)

o   Chillers (Frigo)?

o    

·        Knowledge of Packaging Equipment

o   Pouch Sealing (Multivac)

o   Blister Sealing (Hagmann)

o   Rinsing equipment (Belimed)

Education/Experience:

·        Ability to determine work independently and set priorities to meet the pre-determined

maintenance schedule

·        1-3 years experience working in a clean room with packaging equipment (tray and impulse

sealers) 

·        1-3 years experience working on facility equipment (compressors, vacuum pumps, chillers)

·        Ability to work in a clean room environment wearing required protective clothing -- overalls,

hood (hair covering), mask (mouth), beard cover (if necessary) and shoes 

·        Able to sit and stand for long periods of time 

·        Strong attention to detail 

·        Strong ability to investigate and solve problems

·        Ability to interface with equipment contractors

·        Good hand-eye coordination 

·        High School diploma or equivalent 

·        Additional training or certification on the listed equipment is a plus

·        Able to read, speak, and understand English  

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