Black Swans Exist
Quality Engineer / Resilience Engineer
About the Position
As a Quality Engineer / Resilience Engineer , you will lead investigations of atypical incidents, applying tailored methodologies and collaborating with cross-functional teams to determine root causes and prevent recurrences. Your role will include analyzing data to drive learning and enhance organizational performance, with investigations ranging from Remedial Action Requests (RARs) to high-risk deviations.
You’ll serve as the primary contact for presenting investigation outcomes to customers, the broader organization, and during audits/inspections. Strong communication skills are essential, as you will interact with internal stakeholders, customer representatives, and senior management.
In this role, you’ll employ systematic and analytical approaches, leveraging Human and Organizational Performance (HOP) principles to enrich each quality investigation.
Key Responsibilities
- Lead and facilitate cross-functional investigation teams.
- Proactively manage quality deviations and drive investigations.
- Conduct investigations focusing on performance improvement and risk mitigation in compliance with Pharmaceutical Quality System requirements and regulations.
- Document findings in reports and quality systems, securing necessary approvals within established timelines.
- Share investigation findings and insights internally to support learning.
- Present investigation updates to customers, and represent findings during audits and inspections.
Your Qualifications
- Bachelor’s or Master’s degree in Engineering, or a related scientific discipline.
- Knowledge of drug substance or drug product manufacturing is an asset.
- 5+ years of experience, ideally in an industrial or plant setting.
- Background in performance improvement with a foundation in Human and Organizational Performance principles.
- Familiarity with cGMP, cGLP, and EMEA standards; experience engaging with customers, inspectors, and regulatory agency representatives.
- Strong technical writing skills with an ability to consolidate input from multiple subject matter experts into clear reports.
- Strong facilitation and interpersonal skills for effective stakeholder engagement.
- Demonstrated experience in managing diverse stakeholder needs and balancing competing priorities.
- Analytical skills to interpret data, synthesize insights, and make actionable recommendations.
- Proficiency in English, both written and verbal, with the ability to communicate complex issues clearly.
- Experience in customer-facing roles is advantageous.
