CSL Behring
Senior Principal Engineer, Tech Ops(m/w/x)
Full-timeOn-siteSenior
Bern
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End-to-end lifecycle support for biotherapeutic products and processes. Minimum 5 years in GMP-regulated environments required. Well-being support and cross-functional technical leadership.
Requirements
- Bachelor's, Master's, or PhD in Engineering or Life Sciences
- Minimum 5 years in Process Engineering, MS&T, Process Technology, Validation, or similar
- Experience in GMP-regulated environments and cross-functional teams
- Strong technical problem-solving skills
- Strong data analytics skills
- Strong communication skills
- Strong stakeholder management skills
- Proactive information sharing
- Collaboration across functions
- Accountability for delivering results
- Adjusting priorities to meet changing needs
- Process engineering fundamentals
- Risk assessment
- Troubleshooting
- Equipment qualification
- Data literacy
- Analytical decision-making
- Knowledge of GMP operations
- Knowledge of deviation management
- Knowledge of validation
- Knowledge of lifecycle management
- Strong cross-functional partnering
- Problem solving
- Resilience
- Attention to detail
- Continuous improvement mindset
Tasks
- Serve as a senior technical expert in Technical Operations
- Provide end-to-end lifecycle support for products, processes, and systems
- Bridge Manufacturing, Engineering, and Quality for optimized operations
- Drive continuous improvement and process technology stewardship
- Ensure data-driven decision-making and cross-functional technical leadership
- Align with evolving enterprise strategies and global standards
- Provide subject matter expertise for process, equipment, and product performance
- Serve as a technical reference for complex manufacturing and engineering topics
- Lead or support technology transfer, scale-up/down, and lifecycle management
- Troubleshoot process and equipment issues using structured methodologies
- Close deviations, CAPAs, change controls, and regulatory commitments timely
- Analyze production and analytical data to identify trends and risks
- Apply risk assessment tools in deviation assessments and design decisions
- Contribute to S&I and OPEX/CAPEX projects with technical excellence
- Support conceptual design, user requirements, and process documentation
- Execute continuous improvement initiatives for yield, quality, reliability, efficiency, and cost
- Contribute to global harmonization and standardized processes
- Develop and execute risk-based validation strategies
- Ensure documentation meets regulatory expectations
- Provide technical support during internal and external inspections
- Work cross-functionally with Manufacturing, Quality, Engineering, R&D, and Global Functions
- Facilitate between local operational teams and global technical stakeholders
- Model safety by adhering to site guidelines and mitigating risks
- Provide technical stewardship for site-specific processes and equipment
- Diagnose and resolve process and equipment issues using structured problem-solving
- Apply risk-based methodologies in decision-making
- Lead or contribute to site-level CAPEX/OPEX, CI, and S&I projects
- Drive continuous improvement aligned with CSL standardization efforts
- Develop and maintain validation documentation aligned to global QMS
- Support internal and external inspections with scientific rationale
- Collaborate with manufacturing, engineering, quality, and global partners
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Benefits
Mental Health Support
- Well-being support
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Behring and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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End-to-end lifecycle support for biotherapeutic products and processes. Minimum 5 years in GMP-regulated environments required. Well-being support and cross-functional technical leadership.
Requirements
- Bachelor's, Master's, or PhD in Engineering or Life Sciences
- Minimum 5 years in Process Engineering, MS&T, Process Technology, Validation, or similar
- Experience in GMP-regulated environments and cross-functional teams
- Strong technical problem-solving skills
- Strong data analytics skills
- Strong communication skills
- Strong stakeholder management skills
- Proactive information sharing
- Collaboration across functions
- Accountability for delivering results
- Adjusting priorities to meet changing needs
- Process engineering fundamentals
- Risk assessment
- Troubleshooting
- Equipment qualification
- Data literacy
- Analytical decision-making
- Knowledge of GMP operations
- Knowledge of deviation management
- Knowledge of validation
- Knowledge of lifecycle management
- Strong cross-functional partnering
- Problem solving
- Resilience
- Attention to detail
- Continuous improvement mindset
Tasks
- Serve as a senior technical expert in Technical Operations
- Provide end-to-end lifecycle support for products, processes, and systems
- Bridge Manufacturing, Engineering, and Quality for optimized operations
- Drive continuous improvement and process technology stewardship
- Ensure data-driven decision-making and cross-functional technical leadership
- Align with evolving enterprise strategies and global standards
- Provide subject matter expertise for process, equipment, and product performance
- Serve as a technical reference for complex manufacturing and engineering topics
- Lead or support technology transfer, scale-up/down, and lifecycle management
- Troubleshoot process and equipment issues using structured methodologies
- Close deviations, CAPAs, change controls, and regulatory commitments timely
- Analyze production and analytical data to identify trends and risks
- Apply risk assessment tools in deviation assessments and design decisions
- Contribute to S&I and OPEX/CAPEX projects with technical excellence
- Support conceptual design, user requirements, and process documentation
- Execute continuous improvement initiatives for yield, quality, reliability, efficiency, and cost
- Contribute to global harmonization and standardized processes
- Develop and execute risk-based validation strategies
- Ensure documentation meets regulatory expectations
- Provide technical support during internal and external inspections
- Work cross-functionally with Manufacturing, Quality, Engineering, R&D, and Global Functions
- Facilitate between local operational teams and global technical stakeholders
- Model safety by adhering to site guidelines and mitigating risks
- Provide technical stewardship for site-specific processes and equipment
- Diagnose and resolve process and equipment issues using structured problem-solving
- Apply risk-based methodologies in decision-making
- Lead or contribute to site-level CAPEX/OPEX, CI, and S&I projects
- Drive continuous improvement aligned with CSL standardization efforts
- Develop and maintain validation documentation aligned to global QMS
- Support internal and external inspections with scientific rationale
- Collaborate with manufacturing, engineering, quality, and global partners
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Benefits
Mental Health Support
- Well-being support
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Behring and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
CSL Behring
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein globaler Marktführer in der Biotherapeutik, der innovative Therapien für Patienten mit immunologischen, hämatologischen, kardiovaskulären und anderen Erkrankungen entwickelt.
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