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Senior Computerized Systems Validation (CSV) Engineer (m/f/d)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Engineering, Support, Automotive, Engineer
Projektbeschreibung
REFERENCE NUMBER:
478627/1
MY DUTIES:
- Oversee and perform computer system validation activities at the Solothurn site and ensures the approach and execution aligns to directives and procedures.
- Provide input on improvement of testing documentation after aligning the scope with different stakeholders
- Support the implementation and adoption of the global CSV program and remediation, support data integrity implementation and remediation, articipate in audits and continuous improvement efforts related to CSV program
- Support the on site organization to achieve all CSV site and corporate goals
MY QUALIFICATIONS:
- Bachelor’s Degree from a four year college or university with an emphasis in Engineering/Sciences or equivalent.
- Related experience and/or training; or an equivalent combination of education and experience in the pharmaceutical, biotech or lifescience industry
- Understanding of regulations governing computer systems and control such as FDA’s 21 CFR Part 11, EMA’s Annex 11, and MHRA’s data integrity guidance
- Very good command of English, each other language is of advantage
MY BENEFITS:
- Fascinating, innovative environment in an international atmosphere
- Individual all-round care: Support throughout the entire application phase as well as during the whole duration of the project
- Possibility of contract extension after the first 6 months
ABOUT HAYS:
Our many years of recruitment experience and specialist knowledge of the engineering job market make us a strong partner for engineers and technicians. We maintain intensive relationships with customers across all industries and so can provide engineering specialists with exciting projects and attractive job opportunities. Whether it's working with an international automotive manufacturer or a regional market leader in mechanical engineering, drawing on your interests and experience, we will find the right job to suit you. Because with us, specialists find their ideal working environment – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
MY CONTACT AT HAYS:
My contact person
Samy Georges Henri Birr
Reference number
478627/1
Contact
E-Mail: [email protected]
478627/1
MY DUTIES:
- Oversee and perform computer system validation activities at the Solothurn site and ensures the approach and execution aligns to directives and procedures.
- Provide input on improvement of testing documentation after aligning the scope with different stakeholders
- Support the implementation and adoption of the global CSV program and remediation, support data integrity implementation and remediation, articipate in audits and continuous improvement efforts related to CSV program
- Support the on site organization to achieve all CSV site and corporate goals
MY QUALIFICATIONS:
- Bachelor’s Degree from a four year college or university with an emphasis in Engineering/Sciences or equivalent.
- Related experience and/or training; or an equivalent combination of education and experience in the pharmaceutical, biotech or lifescience industry
- Understanding of regulations governing computer systems and control such as FDA’s 21 CFR Part 11, EMA’s Annex 11, and MHRA’s data integrity guidance
- Very good command of English, each other language is of advantage
MY BENEFITS:
- Fascinating, innovative environment in an international atmosphere
- Individual all-round care: Support throughout the entire application phase as well as during the whole duration of the project
- Possibility of contract extension after the first 6 months
ABOUT HAYS:
Our many years of recruitment experience and specialist knowledge of the engineering job market make us a strong partner for engineers and technicians. We maintain intensive relationships with customers across all industries and so can provide engineering specialists with exciting projects and attractive job opportunities. Whether it's working with an international automotive manufacturer or a regional market leader in mechanical engineering, drawing on your interests and experience, we will find the right job to suit you. Because with us, specialists find their ideal working environment – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
MY CONTACT AT HAYS:
My contact person
Samy Georges Henri Birr
Reference number
478627/1
Contact
E-Mail: [email protected]
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges