Business Technology - Business Technology Engineer

Job description:

• Ensure design control follows scientific rationale, regulatory requirements, internal guidelines, and quality standards, maintaining data integrity and consistent verification testing.
• Apply regulatory and QMS knowledge (ISO, 21CFR820, ISO, EU MDD/MDR) and maintain Design History Files, verification/validation activities, and support for clinical and commercial manufacturing.
• Maintain design control documentation for legacy products and incorporate market feedback, including product complaints, into the DHF.
• Document new equipment and maintain records for existing equipment.
• Ensure design changes follow required Design Control procedures mandated by Health Authorities.
• Support resolution of issues from audits, regulatory inspections, and notified-body interactions by preparing responses and corrective actions.
• Create, review, and approve design control documents (protocols, reports, verification/validation, FMEA, risk management plans, change management plans, design review documentation).
• Maintain DHF content and conformity assessments.
• Ensure targets for quality, timelines, costs, and user requirements are met.
• Provide clear and transparent communication to team members and internal/external partners.

Requirements:

Education & Experience

• Minimum 10 years of device development experience in the pharmaceutical industry.
• Extensive involvement in Change Control and Post-Market Surveillance (ISO, MDR, CAPA processes).
• Focus on lifecycle management of existing products, ensuring compliance and continuous improvement.

Essential Skills, Knowledge & Competencies

• Strong scientific background in primary packaging and drug delivery.
• Experience with Design Control documentation, risk management, and SOP writing.
• Proven ability to work independently and collaboratively across all organizational levels.
• Strong organizational, communication, and self-motivation skills.

Working Conditions

• Flexible work hours and arrangements.
• On-site presence in Bern expected at least 60% of the time.