The Resilience Engineer is responsible for maximizing organizational learning and improvement from Quality deviations and applies systematic and analytical cause analysis techniques inclusive of Human and Organizational Performance principles to each investigation assigned.
Furthermore the Resilience Engineer applies appropriate methodology for each given situation, facilitates investigation team meetings, conducts interviews, and collects and synthesizes data in order to identify causes that if addressed would prevent recurrence. The assigned investigations include cross-site alert actions, remedial action requests, lower risk deviations and AAs RARs.
The main function of the team is to drive the Quality deviation process, to continuously seek the cause of these deviations, explore the extent of the cause or condition and facilitate the identification of meaningful CAPAs to prevent the recurrent of similar incidents.
- Leads investigations for Quality deviations and incidents.
- Conducts Quality investigations with focus on performance improvement and risk reduction, in alignment with Quality Management System requirements and governing regulations.
- Documents investigation reports and findings in designated Quality systems and ensures required management and Quality approvals on final investigations while satisfying established due dates.
- Facilitates internal sharing of investigational findings and risk knowledge. Contributes to metrics related to investigation process and CAPA effectiveness.
Presents investigations during internal and external audits.
About your qualifications and competences
- Bachelor degree or similar in Engineering, Organizational Psychology, Forensics or a related scientific discipline
- A minimum of 5 years of experience in a lab and operations environment (industrial/plant experience preferred)
- Experience in performance improvement with basis in Human and Organizational Performance principles.
- Practical knowledge and application of cGMP, cGLP, EMEA, and OSHA compliance regulations and inspections plus experience interfacing with inspectors, investigators and/or agency personnel.
- Strong technical writing skills and ability to synthesize information from multiple SMEs into a coherent, clear and concise narrative.
- Effective facilitation skills.
- Experience in management of diverse stakeholders with strong interpersonal/influencing skills. Ability to communicate effectively across organizations. Ability to balance resource demands from multiple internal customers.
- Demonstrated ability to analyze, extrapolate data, synthesize and determine recommendations, including the analysis of complex problems.
Please upload your CV and cover letter as soon as possible and latest by 20 January 2020.