Functional Specification Engineer (JO013145) Switzerland
We are URGENTLY looking for a FUNCTIONAL SPECIFICATION ENGINEER
TERMS AND CONDITIONS
Location : Switzaland
Availability : ASAP
The main responsibilities of this position are:
- The position holder acts as technical engineering specialist and is responsible for the FS (functional specification) development
- SPOC (Single Point of contact) for all automation topics within Process Technology and Clean Utilities
- Leading, overviewing and coordinating the FS generation with the lead engineers (scheduling, tracking, prioritization)
- Lead for the alignment within the different FS documents for USP, DSP, shared area to achieve a standardization and uniformity (as far as feasible and applicable)
- Development of the Test strategy and details in alignment with ICQ to fulfil the required qualification steps for the FS
- Development of FS Process with the Manufacturing and Lead Engineers to comply MES requirements
- Planning, Coordination and attending of Reviews (FS and DS) and Tests (FAT)
Technical Responsibilities:
- Developing the details of the qualification approach for the FS
- Ensuring that the FS development and results comply with the qualification approach and accordance with the approved design, local codes and cGMP regulatory requirements
- Archiving an aligned and uniformed FS design within the different suppliers as far as feasible and required
- Driving a modular FS approach
- Identify the required FS documents and development of a gap analysis to identify missing information’s or documents
- Define the required content of the FS in collaboration with the automation team
- Ensure the compliance of all documents with the FS templates
- Involvement in issue resolution and attending coordination meetings between the various engineering disciplines leads to ensure quality and design requirement
- Preparation of qualification documents (RTM, DQ, IQ and OQ) including realization of qualification activities and qualification reports
- SPOC for FS and Automation topics within the Process Technology group and Clean Utilities
- Scheduling and tracking of FS activities as well as review workshops including progress reporting
- Leading and organizing FS workshops to guarantee a consistent design
- Proposing improvement for the FS development and structures
- Reviewing FS documents and give feedback to all involved parties
- 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, master’s 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)
Requirements:
- 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 of process engineering activities as FS Development and PID Design
- Understanding of SIP and CIP functionality and the requirements for the process design
- Knowledge of the functional requirements of a biotech plant and experience with transforming these requirements into specifications
- Understanding the needs for cGMP, GLP & cGxP and qualification.
- Languages: German and/or English fluent in written and spoken
Competencies:
- Technical expertise on biotech processes and hygienic design
- Technical skills as a process engineer to develop and review PID’s, Layouts, FS
- Approachable Team player with advanced communication skills
- Proactive and solution oriented
- Independent an exact working
- Reliable and in time delivery of results
For more informations please send your updated CV and phone number alongside your application