IT Specialist, Manufacturing
- Celgene Corporation
- Date de publication
IT Specialist, Manufacturing
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
PREREQUISITES IT Support Specialist with at least 2 years experience in help-desk and 1 years experience in manufacturing or quality systems support.
Valid Swiss working permission or EU Citizenship required
Celgene is building a new pharmaceutical manufacturing facility for oral dosage forms. This new facility under construction from 2016 will be located in Couvet (NE) and expected to be ready for activities in 2018.
In a first phase, this position will be dedicated to the new plant project for the deployment of the IT processes, infrastructure and systems supporting the design, implementation and operational set up of the new production facility.
In a second step, this position will be based in Couvet and will reinforce the team to maintain and support the Couvet IT operations related to production activities: Product Manufacturing, Quality, Packaging and Logistic.
The position will require a close relationship with the Manufacturing and Quality organizations of Boudry and Couvet, as well as the regional and global IT teams.
All activities below are related and located at the Couvet Manufacturing plant of Celgene International:
1) IT 1st level support in French of the Manufacturing Execution System (MES) and its supporting Hardware such as Desktops, Label Printers, Bar code readers.
2) IT 1st, 2nd, 3rd level support and administration of the Production, Laboratory and Quality related systems such as Chromatography, Room Monitoring System (RMS), etc...
3) Communicate and escalate to 3rd level support, management or vendors in English.
4) IT Incident, Problem Management according to ITIL best practices.
5) Documentation authoring such as Work Practice (WPR) and Standard Operating Procedure (SOP).
6) Quality document authoring such as Change Request (CR), Corrective and Preventive Actions (CAPA) and Deviations.
7) Develop and maintain Knowledge Document for all performed activities to allow cross-training of other IT staff as well as new employees recruited in the future.
8) Collaborate with IT groups to ensure standards are applied for design, technology and compliance.
9) Support the qualification of hardware and validation of software applications in collaboration with specialists in accordance with computer validation policies.
10) Document all activities in order to crosss-train other IT staff that will be recruited in the future.
11) All the above activities may be performed in clean room area.
12) Participation required to duty services in place to cover production shifts.
13) The IT Specialist must be able to move to working place by its own way.
Working Experience & Education
• Diploma in Business and/or Information Systems or equivalent experience.
• Over 1 years in IT Support & Helpdesk activities level 1 & 2
• Over 1 year in IT Support and administration of Manufacturing, Laboratory and Quality systems or equivalent in clean environment is a plus
• Experience & advanced knowledge in the supporting of an MES-system in the pharmaceutical or related industry is a plus.
• Pharmaceutical and/or related industry knowledge is a strong plus.
• Pharmaceutical automation knowledge a plus.
• Transparent, procedural, adaptable, assiduous, sociable, service and team oriented
• Fully operational in French and good knowledge of English (spoken and written).
• Skills in project management and priorities setting.
• Excellent communication and listening skills - ability to work independently.
• Ability to learn and adapt to new situations, systems and processes.
• ITIL Foundations is a plus
• Knowledge of the regulatory pharmaceutical environment.
• GxP, GAMP.
• Knowledge of a MES system (Oracle E-Business Suite a plus)
• Knowledge of a Chromatography (Empower)
• Knowledge of a Data Acquisition System (OSI PI / Kepware) a strong plus
• Knowledge of Automation technologies a plus
• Programming Language: SQL, Windows Script.
• Microsoft Operating Systems & Network
• Microsoft Office Suite