SIP Validation Engineer

☞ Swisslinx

View: 151

Update day: 22-04-2024

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 SIP Validation Engineer. This is a 6-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 ASAP

Location Solothurn

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
  • Partner 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
  • Provide 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 SIP Validation of Large-Scale Upstream Equipment
  • Lead execution of SIP validation PQ runs operating Thermal Validators and Handling BIs
  • Perform LOTO and installs TCs and BIs as per protocol guidance
  • Document PQ in protocols and manages any testing associated deviations to closure
Your profile
  • Degree in an Engineering or Scientific discipline
  • 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
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: 06-06-2024

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