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Scientist, Validation

vor 2 Wochen

Neuenburg, Neuenburg, Schweiz SII Group Switzerland Vollzeit CHF 60'000 - CHF 120'000 pro Jahr

Who we are

SII Group is a trusted technology partner, SII provides high value added solutions for the IT projects of many large corporations. Since its founding in 1979, the Company has been providing solutions adapted to its clients' needs, by relying on :


Its acknowledged expertise in various industries and sectors

Proven 'turnkey' solutions

An efficient quality system

Adaptable, evolving services


Today, with a staff of more than 18'000, SII Group is supporting companies across 20 countries.

At SII Switzerland we pay attention to the personal and professional wellbeing of our employees. We place our collaborators at the heart of our actions and activities. If you are motivated by the perspective of joining a big, trusted and recognized group, then let's meet

To develop our consulting offer and support one of our clients, we are looking for talented Scientist, Validation & Robustness MS&T
.

The Validation & Robustness Scientist is supporting the development and implementation of strategies that ensure Global Commercial Supply is maintained in a constant state of compliance for the good of our patients. Serves as a Subject Matter Expert in a specific Qualification/cleaning validation/process validation/robustness specialty. More specifically, the Validation & Robustness Scientist partners with other MS&T functions to design and execute procedures that guarantee the manufacturing robustness at internal and external sites.

Missions

  • Support the implementation of structures, tools, and processes to actively manage process performance/robustness.
  • Contribute to ensure that new pharma products are launched with an appropriate level of robustness, in collaboration with other MS&T functions and Manufacturing site.
  • Perform analysis of data and draw up robustness boards.
  • Lead the issuing of Continued Process Verification plans and reports.
  • May be assigned Subject Matter Expert (SME) role for a defined validation/qualification area.
  • Ensure equipment, systems and processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
  • Prepare protocols and reports that enable execution of experiments or Technical Batches.
  • Support the completion of investigations led by MS&T by issuing documents or reports.
  • Interface with multiple sites and departments (i.e., Engineering, Facilities, Manufacturing, Regulatory Affairs, Quality Control and Quality Assurance) and suppliers to accomplish predefined goals.
  • Support the development of project plans for validation and qualification activities and ensure results are delivered in a timely manner.
  • Author and when required review validation documents, including but not limited to plans, protocols, reports, traceability matrices and summary reports.
  • Execute validations / qualifications across the site.
  • Lead risk assessments and risk management teams.
  • Review change controls and maintenance interventions, evaluating the impact upon qualified systems & validated processes, and documents required actions.
  • Manage validation projects; including managing time, resources and budgets; own associated change controls.
  • Co-ordinate qualification and validation execution activities, including external vendors and internal departments.
  • Maintain procedures governing validation to ensure they are in compliance with corporate policies and regulatory requirements.
  • Participate when required during internal and external audits for which they are a SME, by answering questions, reviewing qualifications and validations with auditors, and providing documentation.
  • Performs other tasks as assigned.

Profile

  • Degree in Engineering, Chemistry, Pharmacy or Natural Science.
  • Minimum 5 years of experience in pharmaceutical industry and in GMP.
  • Ability to work well as part of a large Project Team.
  • Ability to work across organizational boundaries.
  • Good written and verbal communication and interpersonal skills.

For information

  • Start date: January 2026
  • Location: Neuchâtel – CH
  • Contract: Long term
  • Languages: Fluent in English and French
  • European citizen required