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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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 - 7 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Career Advancement
- Impactful career development
Flexible Working
- Flexible working arrangements
- Flexibility
Informal Culture
- Open culture
- Diverse workforce
- Minimal bureaucracy
Mentorship & Coaching
- Learning from experienced employees
Other Benefits
- Self-developing culture
- Financial and non-financial benefits
Learning & Development
- Training options
Retirement Plans
- Competitive pension fund plan
Bonuses & Incentives
- Annual bonus
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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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 - 7 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Career Advancement
- Impactful career development
Flexible Working
- Flexible working arrangements
- Flexibility
Informal Culture
- Open culture
- Diverse workforce
- Minimal bureaucracy
Mentorship & Coaching
- Learning from experienced employees
Other Benefits
- Self-developing culture
- Financial and non-financial benefits
Learning & Development
- Training options
Retirement Plans
- Competitive pension fund plan
Bonuses & Incentives
- Annual bonus
About the Company
ten23 health
Industry
Pharmaceuticals
Description
The company is a human-centric strategic partner for the pharmaceutical industry and biotech start-ups, focusing on the development and testing of medicines.
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