Global Engineering Commissioning and Qualification Lead
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This is a key leadership role responsible for ensuring that engineering services and processes meet regulatory requirements and quality standards. The successful candidate will lead a team of CQ experts, oversee the generation of protocols for projects such as life cycle documents, commissioning and qualification plans and reports, and align and execute IV/IQ static testing across all site projects.
The GE CQ Lead will collaborate with various departments to increase efficiency in terms of cost and timeline, assess supplier quality department capabilities, and provide technical leadership and guidance for CQV activities according to industry standards.
This role requires strong leadership skills, global interaction capability, financial and commercial acumen, analytical skills, and ability to develop and implement new processes and tools globally.
* Key Responsibilities:
o Lead a team of CQ experts.
o Oversee protocol generation for several projects.
o Commissioning and qualification planning and reporting.
o Align and execute IV/IQ static testing across all site projects.
o Collaborate with departments to increase efficiency in terms of cost and timeline.
o Assess supplier quality department capabilities.
o Provide technical leadership and guidance for CQV activities.
Requirements:
* Master's degree or equivalent experience in Pharma, Engineering, or Science.
* Proven experience in Pharma/Engineering (GEP/GMP) with understanding of Fill and Finish Facility Building and processes.
* Proven experience in Project Management, CQV.
* Proficient in English; German is an advantage.
* Understanding of Pharmaceutical/Bio Science Contract Manufacturing business and experienced in cGM.
* Strong leadership skills with global interaction capability.
* Possess financial and commercial acumen.
* Strong analytical skills.
* Ability to develop and implement new processes and tools globally.