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SIP Validation Engineer / Ingenieur

Swisslinx
Solothurn, Schweiz
Gepostet vor 17 Tagen Befristet Competitive
SIP Validation Engineer / Ingenieur
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)
Job ID  14314
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