CQV Engineer / Ingenieur - SIP Validation

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View: 139

Update day: 17-04-2024

Location: Solothurn Solothurn SO

Category: Quality Assurance / Quality Control

Industry: Staffing Recruiting

Position: Entry level

Job type: Full-time

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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 5 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: As soon as possible

Location: Solothurn

Work type: On site

Duration: 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

Your profile:
  • 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 beneficial
  • 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

To apply or for any further information, please do not hesitate to contact Alina Peeva, recruiter: alina.peeva@swisslinx.com

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

I also hereby agree to the Swisslinx privacy policy (http://www.swisslinx.com/en/legal/privacy-policy) and Terms of Use (http://www.swisslinx.com/en/legal/disclaimer)
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Deadline: 01-06-2024

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