25 Nov

Business Technology - Business Technology Engineer

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.

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