Dein persönlicher KI-Karriere-Agent
Senior Engineer Pharma Operations Engineering Fill & Finish(m/w/x)
Technical authority for aseptic fill-and-finish systems, integrating CAPEX projects into operations. Extensive experience with isolators, filling lines, and freeze dryers required. Flexible working arrangements, learning from experienced employees.
Anforderungen
- Degree in Engineering, Pharmaceutical Technology, Biotechnology, or related technical field
- Extensive, proven experience in Pharma Operations Engineering, focusing on aseptic Fill & Finish processes and complex equipment (isolators, filling lines, freeze dryers)
- Strong background in technical project management and operational readiness, proven track record of transitioning facilities or large-scale CAPEX projects into routine GMP operations
- Deep understanding of global regulatory standards, specific expertise in EU GMP Annex 1
- Demonstrated ability to manage complex deviations, implement CAPAs, and navigate change control processes within a highly regulated environment
- Excellent cross-functional coordination and communication skills, capable of influencing and leading within a matrix organization without direct reporting lines
Aufgaben
- Act as technical authority for fill-and-finish systems
- Ensure reliable and compliant startup of aseptic equipment
- Drive integration of CAPEX projects into operations
- Oversee qualification, validation, and handover processes
- Establish efficient maintenance and performance systems
- Promote standardization, digitalization, and continuous improvement
- Lead matrix-structured projects across departments
- Coordinate with Production, QA, CQV, Warehouse, Tech Support, MSAT, and QC Monitoring
- Manage deviations, CAPAs, and change controls
- Maintain inspection-ready operations and regulatory compliance
Berufserfahrung
- 5 - 7 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Karriere- und Weiterentwicklung
- Impactful career development
Flexibles Arbeiten
- Flexible working arrangements
- Flexibility
Lockere Unternehmenskultur
- Open culture
- Diverse workforce
- Minimal bureaucracy
Mentoring & Coaching
- Learning from experienced employees
Sonstige Vorteile
- Self-developing culture
- Financial and non-financial benefits
Weiterbildungsangebote
- Training options
Betriebliche Altersvorsorge
- Competitive pension fund plan
Boni & Prämien
- Annual bonus
Noch nicht perfekt?
- ten23 healthVollzeitnur vor OrtSeniorVisp
- CH12 Lonza AG
Senior Utilities Operations Expert(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Senior QA Specialist, QA Operations(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Senior Bioprocess Engineer(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Bioprocess Engineer DSP(m/w/x)
Vollzeitnur vor OrtSeniorVisp
Senior Engineer Pharma Operations Engineering Fill & Finish(m/w/x)
Technical authority for aseptic fill-and-finish systems, integrating CAPEX projects into operations. Extensive experience with isolators, filling lines, and freeze dryers required. Flexible working arrangements, learning from experienced employees.
Anforderungen
- Degree in Engineering, Pharmaceutical Technology, Biotechnology, or related technical field
- Extensive, proven experience in Pharma Operations Engineering, focusing on aseptic Fill & Finish processes and complex equipment (isolators, filling lines, freeze dryers)
- Strong background in technical project management and operational readiness, proven track record of transitioning facilities or large-scale CAPEX projects into routine GMP operations
- Deep understanding of global regulatory standards, specific expertise in EU GMP Annex 1
- Demonstrated ability to manage complex deviations, implement CAPAs, and navigate change control processes within a highly regulated environment
- Excellent cross-functional coordination and communication skills, capable of influencing and leading within a matrix organization without direct reporting lines
Aufgaben
- Act as technical authority for fill-and-finish systems
- Ensure reliable and compliant startup of aseptic equipment
- Drive integration of CAPEX projects into operations
- Oversee qualification, validation, and handover processes
- Establish efficient maintenance and performance systems
- Promote standardization, digitalization, and continuous improvement
- Lead matrix-structured projects across departments
- Coordinate with Production, QA, CQV, Warehouse, Tech Support, MSAT, and QC Monitoring
- Manage deviations, CAPAs, and change controls
- Maintain inspection-ready operations and regulatory compliance
Berufserfahrung
- 5 - 7 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Karriere- und Weiterentwicklung
- Impactful career development
Flexibles Arbeiten
- Flexible working arrangements
- Flexibility
Lockere Unternehmenskultur
- Open culture
- Diverse workforce
- Minimal bureaucracy
Mentoring & Coaching
- Learning from experienced employees
Sonstige Vorteile
- Self-developing culture
- Financial and non-financial benefits
Weiterbildungsangebote
- Training options
Betriebliche Altersvorsorge
- Competitive pension fund plan
Boni & Prämien
- Annual bonus
Über das Unternehmen
ten23 health
Branche
Pharmaceuticals
Beschreibung
The company is a human-centric strategic partner for the pharmaceutical industry and biotech start-ups, focusing on the development and testing of medicines.
Noch nicht perfekt?
- ten23 health
Senior Process Expert Aseptic Manufacturing Parenterals(m/w/x)
Vollzeitnur vor OrtSeniorVisp - CH12 Lonza AG
Senior Utilities Operations Expert(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Senior QA Specialist, QA Operations(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Senior Bioprocess Engineer(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Bioprocess Engineer DSP(m/w/x)
Vollzeitnur vor OrtSeniorVisp