DQ Engineer – Design Qualification Engineer

DQ Engineer – Design Qualification Engineer (JO013144) Switzerland

The main responsibilities of this position are:

The position holder acts as qualification engineering specialist and is responsible for the life cycle document management and design qualification
SPOC (Single Point of contact) for all design qualification topics within Process Technology and Clean Utilities
Leading, overviewing and coordinating the life cycle document generation with the lead engineers (scheduling, tracking, prioritization)
Fulfill the requirements of the DQ strategy in alignment with ICQ guidelines
Development of the RTM (Requirement Traceability Matrix) as a basis for the design qualification
Planning, Coordination and attending of Reviews

Technical Responsibilities

Developing the details of the qualification approach for the Life cycle documents (RS, RA, DS, COTS, FS, RTM)
Ensuring that the life cycle documents comply with the qualification approach as well as local codes and cGMP regulatory requirements
Identify the required life cycle documents and development of a gap analysis to identify missing information’s or documents
Ensure that all project changes are documented in the life cycle documents
Ensure the compliance of all documents with the valid templates
Involvement in issue resolution and attending coordination meetings between the various engineering disciplines leads to ensure quality and design requirement
Leading and preparation of the RTM and other required qualification documents
SPOC for design qualification topics within the Process Technology group and Clean Utility
Scheduling and tracking of documentation and DQ activities and preparing a progress report
Proposing improvement for the DQ and life cycle documents development and structures
Bears responsibility and accountability for working according to cGxP, health, safety and environmental requirements as laid out in the CSL SOPs and procedures as well as all relevant external / governmental guidance.

Education

Degree (Bachelor, Masters or higher) in mechanical, process or chemical engineering, Dipl. lng. or M.Sc. or B.Sc. or equivalent
Languages: English fluent in writing and spoken (B2)

Experience

5-10 years of experiences in the pharmaceutical, chemical or food industry as a project engineer
Experience and knowledge in biotech process
Proofed Experience and Knowledge for the development of life cycle documents and RTM’s
Experience and Knowledge for design qualification approaches
Knowledge of the requirements for a biotech plant and experience with transforming these requirements into life cycle documents
Understanding the needs for cGMP, GLP & cGxP and qualification
Languages: German and/or English fluent in written and spoken

Competencies