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Validation Engineer
View: 142
Update day: 18-03-2024
Category: Quality Assurance / Quality Control
Industry: Civil Engineering
Position: Entry level
Job type: Contract
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Job content
Candidates from EU who would like to relocate to Switzerland are welcomedExperis IT is on the search for a Validation Engineer to join one of their clients, a well-known pharma company based in Switzerland. This exciting temporary opportunity is only open to candidates with relevant experience. If you’re looking to take your career to the next level, please read on!Contact:Francesca De ChiricoStart Date: ASAPDuration:6months -chance of further contract extensionLocation: Baar, Hybrid ModelWorkload percentage: 100%Key Responsibilities- Preparation and execution of validation protocols involving facilities, equipment, utilities, and associated automation.
- Preparation and supporting deviations, change controls, validation summary reports and associated documentation.
- Management and co-ordination of validation activities with internal departments, external contractors, and suppliers.
- Prepare and deliver cross functional training in validation methodologies, protocols, and related procedures to facilitate validation activities.
- Partners with cross functional departments to perform deviation root cause analysis and formulate corrective/preventative actions (CAPA).
- Performance of risk and impact assessments/FMEA as required.
- Provides support to commissioning activities, including review of commissioning plans, procedures, turnover packages etc.
- Perform final review of test data/reports to ensure conformance with established specifications and related SOPs.
- Provide guidance as a subject matter expert (SME) for Validation of Facilities, Utilities and Equipment.
- Lead execution of validation for assigned systems.
- Documents Validation execution in protocols and manages any testing associated deviations to closure.
- 5+ years of experience in a Validation role in a biopharmaceutical manufacturing environment is a must have.
- Thorough knowledge of biotechnological technologies, processes, and equipment.
- Demonstrated proficiency working in Biopharma. Knowledge of industry regulations as they relate to validation.
- Experience using DeltaV is a must.
- Experience with Pi, Syncade and PLC systems a benefit.
- Experience with Bioreactors systems for mAb production is a big advantage.
- Highly motivated to take ownership and responsibility for assignments.
- Ability to take the initiative with minimal supervision.
- Proficiency in MS Word and MS Excel essential. Experience with LIMS is an advantage.
- Strong technical writing and communication skills in English (Fluent/Level C mandatory).
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Deadline: 02-05-2024
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