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FUNCTIONAL SPECIFICATION ENGINEER

MPH CONSULTING SERVICES DMCC

Posted on August 9, 2018

5 - 10 years Switzerland - Switzerland

Master of Science, Master of Pharmacy(Pharmacy), Master of Technology/Engineering(Chemical, Mechanical), Bachelor of Science, Diploma(Chemical, Mechanical), Bachelor of Technology/Engineering(Chemical, Mechanical). Any European National

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Job Description

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We are recruiting a “Functional Specification Engineer ' for one of the leading company in Swizerland .

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.


FMCG / Foods / Beverages

Engineering

Desired Candidate Profile

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)

Preference:
English and German speaking in the pharmaceutical construction sector/ design phase

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

Location: Switzerland

If you are interested in this project, kindly please filled in the table below and send it along with your most updated CV.

Your prompt response will be highly appreciated. If you are not interested or not available to pursue this opportunity, please do not hesitate to refer your friends/colleagues who would fit the role.

Keywords

Functional Specification Engineer functional specification fs SPOC Single Point of contact coordinating scheduling tracking prioritization USP DSP ICQ cGMP RTM SPOC for FS SOPs B2 pharmaceutical chemical food PID Design cip

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MPH CONSULTING SERVICES DMCC

Our Group, MPH, founded in 1985, currently has over 800 consultants worldwide providing personnel to the Oil & Gas Industry Onshore and Offshore, Naval Construction, Nuclear Industry, Health, Safety & Environment and Water Treament.
Since 1985, Availability of senior project expatriate engineer s for your current and future projects.



MPH specializes in providing specific personnel for key projects & senior engineering / construction disciplines such as:

- Engineering (basic and detailed multidisciplines)
- PMC Engineering / Construction Services
- Project Management for major EPC contracts
- Construction Management and various construction disciplines.
- Commissioning, Start-up / Production
- Marine Operations
- Maintenance and shut-down Operations
- Health, Safety & Environment
- IT, Change Management

Our current personnel may be mobilized rapidly for the various projects in hand worldwide. Our Companies are dedicated to international projects.
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