Lab Manager Testing Switzerland

vor 2 Wochen

Zug, Schweiz SHL Medical AG Vollzeit

Location: Zug, Switzerland

SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States.

**Job Overview**

The position of Lab Manager Testing is responsible of establishing and operating a modern testing lab, and contributing to the implementation and improvement of the QMS processes and best practices in the Lab. He/she will support with the expansion of our testing capabilities to support upcoming pipeline, as well as implementation of asset and data management systems. He/she would manage and/or execute testing tasks during product development as needed. The position of Lab Manager Testing reports to the Head of Testing Switzerland.

**Main Responsibilities**
- Building up a new and operational testing lab (in Zug, CH) in alignment with the global testing strategy - Acquired and maintain lab infrastructure
- Proactive involvement in CAPEX/OPEX planning/expenditure
- Manage and/or execute testing tasks during product development
- Develop and implement new SOPs/WI/templates, review and optimize them
- Ensure conformity of lab quality to SOPs/WIs and standards
- Obtain equipment and supplies needed to maintain Laboratory operation
- Prepare laboratory documents, reports, and records to meet internal and external requirements
- Plan and lead through audits
- Proactively identify, mitigate, and track recurring compliance issues
- Plan, prepare and execute tests according to protocol / test instructions independently - Develop new test methods
- Participate actively in the selection of the external labs and lead these external testing labs
- Support implementation of Team center, EAM, and global data management system (within Testing & Simulation)
- Provide expertise in the field of Combination Products and drug delivery systems performance testing to contribute to the assigned projects/duties
- Pro-active communication of status, progress, results, and knowledge with internal and external stakeholders

**Skills and Qualification**
- University degree in the field of biomechanics, mechanical engineering, mechatronics, health sciences and technology or a related field of study. In lieu of a degree, 10 or more years of relevant experience may suffice.
- Minimum of 5 years of experience in laboratory management in MedTech or highly regulated industry
- Proven record to develop and implement good laboratory practices
- Experience with CAPEX process
- Able to handle lab equipment of various industrial measurement technologies (force, torque, optical, multisensory,)
- Knowledge and working experience to perform sample preparation, pre-conditioning, assembly.
- Experience in writing test protocols/reports and quality records
- Ability to analyze technical problems and systematically develop detailed solutions
- Ability to work effectively with other departments (global and multicultural)
- Ability to maintain effective communication with internal and external stakeholders.
- Open-minded, proactive, persistent, results
- and execution-oriented, and able to work under pressure in changing environments
- Fluent in English and German languages, written and spoken.
- Team player and self-starter, able to perform with mínimal supervision - This position requires work to be done in person and on site (Zug)

**We Offer**
- An exciting opportunity in a fast-growing international medical device company
- A modern working environment, with multicultural and dynamic teams
- Flexible working hours and a hybrid remote work policy
- A centrally located office in Zug, very close to the train station

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