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CQV Engineer – SIP Validation
View: 141
Update day: 04-04-2024
Location: Solothurn Solothurn SO
Category: Quality Assurance / Quality Control
Industry: Staffing Recruiting
Position: Mid-Senior level
Job type: Contract
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Job content
On behalf of our client, an international Biotechnology company based in Solothurn, Swisslinx is looking for a CQV Engineer. This is initially a 4 months contract position (extension possible) with a great opportunity to bring your proven knowledge and expertise to an organization that offers a dynamic working environment.Start Date July 2023
Location Solothurn
Work type On site
Duration 4-5 months
Extension Possible
Your mission
- 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.
- Performs final review of test data / reports to ensure conformance with established specifications and related SOPs
- Provide guidance as a subject matter expert (SME) for SIP Validation of Large-Scale Upstream Equipment
- Lead execution of SIP validation PQ runs operating Thermal Validators and Handling BIs
- Performs LOTO and installs TCs and BIs as per protocol guidance
- Documents PQ in protocols and manages any testing associated deviations to closure
- 3+ years of experience in a Validation role in a biopharmaceutical manufacturing environment 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
- Strong technical writing and communication skills in English (Fluent/Level C mandatory)
- Experience using DeltaV is a must
- Experience with Kaye Validators, TCs and BIs is essential
- 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
By applying for this position, I consent to the Swisslinx Group of companies
- storing my personal information (including name, contact details, Identification and CV information etc.) on their internal or external servers for the purpose of informing me of potential employment opportunities
- using my personal information or
- supplying it to third parties upon express consent for the purpose of informing me of potential job opportunities
- transferring where applicable my personal information to a country outside the EEA/EFTA
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Deadline: 19-05-2024
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