Process validation engineer

vor 13 Stunden

Neuenburg, Schweiz Antaes Consulting Vollzeit

Direct message the job poster from Antaes Consulting

To join our Life sciences team in Neuchâtel, we are looking for a MSAT Validation Senior Scientist (F/M).

Your Role :

  • Develop, implement and manage the site process validation, and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs.
  • Collaborate with cross functional teams to define the interfaces to equipment qualification / utilities qualification, system qualification and analytical method validation.
  • Establish and maintain the Validation Master Plan for process validation. Ensure that all manufacturing processes are validated, overview on state of validation at site is maintained.
  • Participate in transfers and launches, liaise with technical development for new products and align on the product validation approach. Contribute to provide experimental data obtained during the validation activities, which will be used to prepare the related registration documentation.
  • Author or reviewer for routine validation protocols and reports, associated change controls and supports the execution at the shop floor.
  • Develop the strategy for continued process verification that ensures all critical process parameters and quality attributes are monitored or analysed, and actions are defined and taken in case of trends or deviations. Reviews plans for CPV.
  • Lead and drive investigation for validation related matters and implement corrective and preventive actions.
  • Contribute to all relevant audit inspection and ensure inspection readiness for the site. Ensure compliance with relevant regulatory requirement, GMP, and other industry standards.

Your Profile :

  • Engineer/university degree in Biotechnology, Chemistry or Biology or similar.
  • 5 years of experience in biotech process engineering / process design and validation.
  • Experience in GMP production environment.
  • Project and change management experience.
  • Experience with Product Life Cycle Management.
  • Experienced in Health Authority inspections with direct interactions including face to face interaction and response to audit questions.
  • Good communication and proactivity.
  • Team spirit, easiness in a multidisciplinary environment.
  • Fluent in French and English.

-----------------------------------------------------------

Founded in 2007, Antaes is a Swiss management and technology consulting company ranked 7th among consulting companies in French-speaking Switzerland. We have over 300 experienced engineers who share our passion.

With offices in Switzerland, Singapore, Hong Kong and France, we support our Swiss and international clients in the following areas:

  • Organisation and transformation consulting.
  • Information Systems Management.

By joining our team you will discover:

  • A dynamic team in a start-up spirit.
  • A human accompaniment and a follow-up of your career development.
  • Challenges to contribute to the development of your network.
  • A company certified @HappyAtWork and with a committed CSR policy (Ecovadis2023 gold medal).

You too can be part of the Antaes adventure

Seniority level

Associate

Employment type

Full-time

Job function

Engineering and Consulting

Industries

Engineering Services, Pharmaceutical Manufacturing, and Biotechnology Research

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