Maintenance Technology Lead

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