Certified Commissioning Specialist for Global Projects
Vor 4 Tagen
We are seeking a highly skilled Certified Commissioning Specialist to join our team at CSL Behring.
About the RoleThis is a unique opportunity to work on complex projects, ensuring compliance with global and local policies, standards, and regulations. As a Certified Commissioning Specialist, you will be responsible for planning, coordinating, and executing commissioning and qualification activities for CAPEX- and OPEX-projects.
You will facilitate the development, review, and approval of technical and GMP-related documentation, including URS, impact/risk assessment, Master plans, qualification/validation documentation. Additionally, you will develop C&Q verification documents, such as Commissioning/Qualification plans, FMEA, IQ, OQ, and execute verification activities.
As a key member of our team, you will collaborate with internal and external partners to coordinate and oversee vendor FAT/SAT, commissioning activities. You will also plan and execute PQ's, including sterilization/depyrogenisation cycle development, Smoke Study, Temperature/Humidity mapping.
Your responsibilities will also include assessing and handling Change Controls, CAPAs, and Non-Conformances related to qualification topics. You will work closely with stakeholders from Process Engineering, Project Delivery, Execution Systems, PALM Validation, PALM Stability, Value Streams, R&D, QC staff, and others to ensure efficient project delivery.
In this role, you will have the opportunity to support multi-site projects, delivering on company key CapEx projects and providing management support to ensure successful project outcomes.
Requirements- Master degree in a relevant science or engineering discipline
- Proven work experience in biotech or pharma company in an cGxP environment and/or C&Q equivalent position
- Experience and knowledge in sterilization/dehydrogenization is a plus
- Knowledge of Commissioning and Qualification requirements according to cGMP regulations and international guidelines
- Excellent written English communication skills
- Ability to communicate clearly and effectively
- Analytical thinking and problem-solving ability
- Self-time management
- Excellent team player
Career advancement opportunities within the company
$120,000 - $160,000 per year salary package, depending on experience
Comprehensive benefits package, including health insurance, retirement savings, and paid time off
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