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Training and Documentation Specialist(m/w/x)
Training and documentation for drug product manufacturing at a global life sciences firm, in classroom and shopfloor settings. MES recipe authoring experience, especially Emerson Syncade, and sterile drug product process knowledge required. Role as change agent for quality improvement.
Requirements
- Studies in Pharmaceutical Technology, Chemistry, or Pharmacy
- Experience in MES recipe authoring, preferably in Emerson Syncade
- Process knowledge in sterile drug product
- Knowledge of DeltaV
- Familiarity with regulated environment, cGMP, 21CRF part 11, and validation requirements
- Proficiency in German and English
- Familiarity with GMP requirements, quality procedures, and SOP execution
- Good interpersonal skills and interaction with various interfaces
- Structured, focused, and well-organized working demeanor
- Motivation and problem-solving attitude
Tasks
- Act as a change agent in the Drug Product department
- Conduct training activities for operators and scientists
- Align training programs with quality and business goals
- Develop training strategies and materials for various levels
- Provide training in classroom and shopfloor settings
- Assess trainees’ competencies and qualifications
- Write and adapt department-specific SOPs
- Execute manufacturing activities according to cGMP guidelines
- Evaluate test results and troubleshoot manufacturing equipment
- Prepare and review electronic batch records
- Review production documentation and manage deviations
- Implement change requests and CAPAs to maintain GMP standards
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- Emerson Syncade
- DeltaV
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- CH12 Lonza AGFull-timeOn-siteJuniorVisp
- Lonza
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Training and Documentation Specialist(m/w/x)
Training and documentation for drug product manufacturing at a global life sciences firm, in classroom and shopfloor settings. MES recipe authoring experience, especially Emerson Syncade, and sterile drug product process knowledge required. Role as change agent for quality improvement.
Requirements
- Studies in Pharmaceutical Technology, Chemistry, or Pharmacy
- Experience in MES recipe authoring, preferably in Emerson Syncade
- Process knowledge in sterile drug product
- Knowledge of DeltaV
- Familiarity with regulated environment, cGMP, 21CRF part 11, and validation requirements
- Proficiency in German and English
- Familiarity with GMP requirements, quality procedures, and SOP execution
- Good interpersonal skills and interaction with various interfaces
- Structured, focused, and well-organized working demeanor
- Motivation and problem-solving attitude
Tasks
- Act as a change agent in the Drug Product department
- Conduct training activities for operators and scientists
- Align training programs with quality and business goals
- Develop training strategies and materials for various levels
- Provide training in classroom and shopfloor settings
- Assess trainees’ competencies and qualifications
- Write and adapt department-specific SOPs
- Execute manufacturing activities according to cGMP guidelines
- Evaluate test results and troubleshoot manufacturing equipment
- Prepare and review electronic batch records
- Review production documentation and manage deviations
- Implement change requests and CAPAs to maintain GMP standards
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- Emerson Syncade
- DeltaV
About the Company
CH12 Lonza AG
Industry
Healthcare
Description
The company is a global leader in life sciences, dedicated to improving lives through innovative solutions.
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