Engineer Qualification Validation
The Qualification & Validation Engineer performs validation and qualification activities. They assure compliance of these activities with cGMP as well as with internal policies and procedures.
The Engineer has demonstrated experience of managing validation projects, on time and within budget.
- May be assigned Subject Matter Expert role for a defined validation/qualification area.
- Develop and justify the validation approach based on risk and scientific rational
- Ensure equipment, systems and processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures.
- Author and when required review validation documents, including requirement specifications, validation plans, protocols, reports, traceability matrix and summary reports.
- Contributes to the development and maintenance of the site procedures.
- Lead risk assessments and risk management teams
- Review change controls and maintenance interventions, evaluating the impact upon qualified systems & validated processes, and documents required actions
- Co-ordinate qualification and validation execution activities, including external vendors and internal departments.
- BS/MS in Engineering/Technical discipline or equivalent experience
- 5 years experience in pharmaceutical Validation or related field
- Communicates pro-actively and collaboratively
- Team player: ability to interact effectively with team and customers
- Good level of English
- Ability to communicate in French