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Validation Engineer

Validation Engineer

StandorteNeuchatel, Switzerland
Kontakt E-Mails.mccormack@panda-int.com
Job ref21938
Publiziert17 days ago

We are currently seeking Validation Engineers for various positions located in Switzerland. Our openings encompass both short and long-term contracts, exclusively within the biotechnology sector at on-site locations.

We are in search of Junior, Intermediate, and Senior Validation Engineers who can leverage their expertise and competencies to guide our projects to successful completion.

Ideal candidates should possess a strong emphasis on the execution of Commissioning, Installation & Operational Qualification (IQ/OQ), and Verification for downstream process equipment, CIP (Clean-in-Place), and Clean utilities. Additionally, a background in GMP/GDP standards and a Level 8 degree in a science or engineering-related field is highly preferred.

Our interview process consists of a single-stage interview conducted via Teams, followed by prompt job offers. Don't hesitate; take action today!

Responsibilities:

  1. Planning, implementing, coordinating, and documenting process validation activities within the scope of development projects, and in special cases, within the scope of (re-)certification projects.
  2. Serve as a core team member in larger development projects.
  3. Review related documentation within the scope of development projects.
  4. Manage, implement, and evaluate test method and process validations.
  5. Plan, coordinate, and monitor mechanical and analytical test procedures during validations, including raw data evaluation, report preparation, review, and release.
  6. Provide support to production during transfer and deliver training on quality-relevant content.
  7. Continuously improve processes and procedures through evaluation and analysis, ensuring readiness for project transfer to production.
  8. Develop and deploy competences in the area of design control and risk management.
  9. Collaborate in interdepartmental expert groups in the field of process verification and validation.

Qualifications:

  1. A degree at Level 8 in Engineering or a science-related field.
  2. A minimum of 3 years of experience in the Life Sciences industry.
  3. Experience with DeltaV and process equipment start-up is advantageous.
  4. Previous experience working within project environments.
  5. A proactive, hands-on approach, particularly in functional testing of equipment.
  6. Strong oral and written communication skills in English.
  7. Fluent in English, and French is also desirable.

Additional Requirements:

  1. Master's or PhD in health science and technology, biotechnology, pharmaceutical, medical technology, or engineering field.
  2. Knowledge of international regulatory requirements in the field of vascular intervention for risk management, process verification and validation, and test method validations (including MDR, MDD, QSR, ISO 13485, ISO 14971, ISO 9001, cGxP).
  3. Application of statistical methods.
  4. Six Sigma Green Belt or similar (knowledge of methods such as DFSS, DMAIC, DoE, FMEA, etc.).

Applications from Switzerland and the EU only will be considered. Please note that due to Brexit, we are no longer accepting applications from the UK. To explore this exciting opportunity further, please send your CV and contact number to s.mccormack@panda-int.com without delay!