Dein persönlicher KI-Karriere-Agent
Senior Principal Engineer, Tech Ops(m/w/x)
Global technical leadership for biotherapeutic product and process lifecycles. Advanced degree and 7+ years in regulated pharma/biotech operations required. Well-being support and global initiative leadership.
Anforderungen
- Bachelor’s degree in Engineering, Life Sciences, or related discipline
- Advanced degree (MS or PhD) strongly preferred
- 7+ years in pharmaceutical/biotech operations, MS&T, Process Engineering, Process Technology, or related
- Expertise leading global or crosssite programs, major capital projects, or enterprise transformations
- Significant experience supporting regulated environments (GxP, OSHA, EPA), including inspections
- Track record of technical leadership, complex problem solving, and strategic influence
- Expertise in global lifecycle management and multi-site operations
- Capability in data-driven strategy and network-level performance oversight
- Understanding of regulatory expectations and inspection readiness globally
- Executive communication and stakeholder influencing
- Strategic decision making under complexity
- Ability to drive harmonization and change across cultures and geographies
Aufgaben
- Serve as global technical leader and SME
- Provide guidance across product and process lifecycle
- Influence strategy and drive global improvements
- Ensure robust, compliant, and efficient operations
- Lead complex, cross-site or global initiatives
- Mentor technical staff
- Represent function in high-impact forums
- Provide authoritative technical guidance across sites
- Represent MS&T in global governance bodies
- Participate in design reviews and strategic initiatives
- Steward defined process families, technology platforms, or system categories
- Provide expert input for technology strategy and roadmaps
- Oversee lifecycle performance of processes, equipment, and products
- Lead or direct technology transfer, scale-up/scale-down, and modernization projects
- Drive harmonized standards and best practices
- Serve as escalation point for complex, multi-site technical challenges
- Facilitate structured problem solving and data-driven decisions
- Resolve high-risk deviations and CAPAs
- Ensure enterprise learning and preventive improvements
- Analyze production and analytical data
- Identify trends and prioritize improvements
- Guide use and maturity of risk-based tools
- Lead or contribute to global S&I and OPEX/CAPEX projects
- Ensure technical execution aligns with regulatory expectations
- Provide technical due diligence and conceptual design input
- Define and lead network-level continuous improvement initiatives
- Advance global harmonization and standardization efforts
- Develop risk-based validation strategies
- Contribute to inspection readiness activities
- Review high-impact technical justifications and regulatory submissions
- Lead multi-site, multi-functional teams
- Serve as trusted strategic partner to various functions
- Build consensus across diverse stakeholders
- Influence without authority
- Model safety culture and mitigate risks
- Mentor engineers, scientists, and site personnel
- Support development of training materials and standards
- Act as thought leader in industry forums
- Lead complex or high-impact cross-site investigations
- Guide multi-site technology transfer and modernization
- Define and lead global continuous improvement programs
- Contribute to global validation approaches
- Support regulatory submissions
- Represent MS&T in global governance forums
- Mentor engineers and build technical capability
- Collaborate with senior leaders to align global priorities
Berufserfahrung
- 7 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Mentale Gesundheitsförderung
- Well-being support
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Senior Principal Engineer, Tech Ops(m/w/x)
Global technical leadership for biotherapeutic product and process lifecycles. Advanced degree and 7+ years in regulated pharma/biotech operations required. Well-being support and global initiative leadership.
Anforderungen
- Bachelor’s degree in Engineering, Life Sciences, or related discipline
- Advanced degree (MS or PhD) strongly preferred
- 7+ years in pharmaceutical/biotech operations, MS&T, Process Engineering, Process Technology, or related
- Expertise leading global or crosssite programs, major capital projects, or enterprise transformations
- Significant experience supporting regulated environments (GxP, OSHA, EPA), including inspections
- Track record of technical leadership, complex problem solving, and strategic influence
- Expertise in global lifecycle management and multi-site operations
- Capability in data-driven strategy and network-level performance oversight
- Understanding of regulatory expectations and inspection readiness globally
- Executive communication and stakeholder influencing
- Strategic decision making under complexity
- Ability to drive harmonization and change across cultures and geographies
Aufgaben
- Serve as global technical leader and SME
- Provide guidance across product and process lifecycle
- Influence strategy and drive global improvements
- Ensure robust, compliant, and efficient operations
- Lead complex, cross-site or global initiatives
- Mentor technical staff
- Represent function in high-impact forums
- Provide authoritative technical guidance across sites
- Represent MS&T in global governance bodies
- Participate in design reviews and strategic initiatives
- Steward defined process families, technology platforms, or system categories
- Provide expert input for technology strategy and roadmaps
- Oversee lifecycle performance of processes, equipment, and products
- Lead or direct technology transfer, scale-up/scale-down, and modernization projects
- Drive harmonized standards and best practices
- Serve as escalation point for complex, multi-site technical challenges
- Facilitate structured problem solving and data-driven decisions
- Resolve high-risk deviations and CAPAs
- Ensure enterprise learning and preventive improvements
- Analyze production and analytical data
- Identify trends and prioritize improvements
- Guide use and maturity of risk-based tools
- Lead or contribute to global S&I and OPEX/CAPEX projects
- Ensure technical execution aligns with regulatory expectations
- Provide technical due diligence and conceptual design input
- Define and lead network-level continuous improvement initiatives
- Advance global harmonization and standardization efforts
- Develop risk-based validation strategies
- Contribute to inspection readiness activities
- Review high-impact technical justifications and regulatory submissions
- Lead multi-site, multi-functional teams
- Serve as trusted strategic partner to various functions
- Build consensus across diverse stakeholders
- Influence without authority
- Model safety culture and mitigate risks
- Mentor engineers, scientists, and site personnel
- Support development of training materials and standards
- Act as thought leader in industry forums
- Lead complex or high-impact cross-site investigations
- Guide multi-site technology transfer and modernization
- Define and lead global continuous improvement programs
- Contribute to global validation approaches
- Support regulatory submissions
- Represent MS&T in global governance forums
- Mentor engineers and build technical capability
- Collaborate with senior leaders to align global priorities
Berufserfahrung
- 7 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Mentale Gesundheitsförderung
- Well-being support
Über das Unternehmen
CSL Behring
Branche
Pharmaceuticals
Beschreibung
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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