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
- 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
- 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: email@example.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