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Group Lead Qualification Engineer(m/w/x)
Leading qualification activities for human plasma and cell line medicines. 5+ years IQ/OQ/PQ experience with manufacturing equipment required. Employee and leadership trainings, trainee programs.
Requirements
- University degree in technical field
- 5+ years experience in qualification, validation, technical engineering, or manufacturing support
- Strong knowledge of IQ/OQ/PQ and lifecycle qualification principles
- Experience with manufacturing equipment, utilities, or facility systems
- Experience in pharmaceutical manufacturing industry
- Understanding and experience with engineering development models and design documentation preparation
- Ability to act independently and collaborate effectively with cross-functional teams
Tasks
- Lead and coordinate qualification activities
- Plan and execute IQ/OQ for systems and facilities
- Support global and multi-site engineering projects
- Develop and maintain qualification standards
- Coordinate qualification of production equipment
- Review qualification documentation and reports
- Ensure compliance with internal and regulatory standards
- Work with site engineering and maintenance teams
- Support troubleshooting and root cause investigations
- Drive harmonization of qualification practices
- Provide technical guidance and training
- Identify opportunities to improve efficiency
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Learning & Development
- Employee and leadership trainings
- Trainee programs
Modern Equipment
- Digital solutions
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Group Lead Qualification Engineer(m/w/x)
Leading qualification activities for human plasma and cell line medicines. 5+ years IQ/OQ/PQ experience with manufacturing equipment required. Employee and leadership trainings, trainee programs.
Requirements
- University degree in technical field
- 5+ years experience in qualification, validation, technical engineering, or manufacturing support
- Strong knowledge of IQ/OQ/PQ and lifecycle qualification principles
- Experience with manufacturing equipment, utilities, or facility systems
- Experience in pharmaceutical manufacturing industry
- Understanding and experience with engineering development models and design documentation preparation
- Ability to act independently and collaborate effectively with cross-functional teams
Tasks
- Lead and coordinate qualification activities
- Plan and execute IQ/OQ for systems and facilities
- Support global and multi-site engineering projects
- Develop and maintain qualification standards
- Coordinate qualification of production equipment
- Review qualification documentation and reports
- Ensure compliance with internal and regulatory standards
- Work with site engineering and maintenance teams
- Support troubleshooting and root cause investigations
- Drive harmonization of qualification practices
- Provide technical guidance and training
- Identify opportunities to improve efficiency
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Benefits
Learning & Development
- Employee and leadership trainings
- Trainee programs
Modern Equipment
- Digital solutions
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Octapharma
Industry
Pharmaceuticals
Description
Das Unternehmen ist eines der weltweit größten, das humane Proteine aus menschlichem Plasma und humanen Zelllinien entwickelt und herstellt.
Not a perfect match?
- Octapharma Pharmazeutika Produktionsges.m.b.H.
Group Lead Engineer - Technical Unit(m/w/x)
Full-timeOn-siteManagementWien, Springefrom 4,686.11 / month - Die Chemgineering Gruppe
Lead Qualifizierung und Validierung Ingenieur(m/w/x)
Full-timeOn-siteSeniorWien - Octapharma Pharmazeutika Produktionsges.m.b.H.
Group Lead Engineer Fill & Finish - Technical Unit(m/w/x)
Full-timeOn-siteSeniorWien, Springefrom 4,270.14 / month - Octapharma Pharmazeutika Produktionsges.m.b.H.
Group Automation Engineer(m/w/x)
Full-timeOn-siteSeniorWien, Springefrom 4,270.14 - Octapharma Pharmazeutika Produktionsges.m.b.H.
Group Senior Expert - API Production(m/w/x)
Full-timeOn-siteSeniorWien, Springefrom 4,270.14 / month