Validation Engineer
Randstad
Luterbach, Solothurn, CH
vor 11 Tg.

Randstad Professionals is currently looking for a Validation Engineer who will be assigned an interesting challenge for a major client based close to Solothurn.

This contract is an unique opportunity to join a major client, global group focusing on the Healthcare / Biotechnology sector.

The initial assignment will start immediately and will last until December 2019

Contract details :

Start Date : 11 / 03 / 2019

Requisition End Date : 31 / 12 / 2019

Assignment overview

The role is responsible for writing, performance and reporting on validation activities related to biopharmaceutical Facilities, Utilities, Equipment (FUE) and associated systems (e.

g. automation). The validation engineer shall be responsible for planning, coordination and driving validation activities from initiation to successful completion.

The individual shall act as the primary decision maker for assigned validation responsibilities, including deviation investigations, risk / impact assessment.

Accountability Description

Primary tasks (60%)

1. Preparation and execution of validation protocols involving facilitates equipment, utilities and associated automation.

2. Preparation, review and approval (as required) of SOPs, validation deviations, change control, validation summary reports and associated documentation.

3. Preparation, review and approval Validation Master Plan (if required)

4. Management and co-ordination of validation activities with internal departments, external contractors and suppliers.

5. Prepare and deliver cross functional training in validation methodologies, protocols and related procedures to facilitate validation activities.

6. Primary point of contact for validation related issues arising during validation activities (including protocol execution).

7. Ensure site Validation Program meets company global directive, procedures and other related compliance / regulatory documents.

Secondary tasks (40%) :

1. Investigation of deviations / non-conformances to determine potential impact on product quality, validation status and associated compliance requirements.

2.Review and approve Change Management applicable to any system that needs to be qualified. 3. Partners with functional departments to perform deviation root cause analysis and formulate corrective / preventative actions (CAPA).

4. Performance of risk and impact assessments associated with validation activities, deviations and changes.

3. Provides support to commissioning activities, including review of commissioning plans, procedures, turnover packages etc. (as required).

4. Review Commissioning Master Plan to ensure accuracy with established Engineering Guidelines and Specifications.

5.Performs final review of test data / reports to ensure conformance with established specifications and related standard operating procedures.

6.Provide guidance on validation requirements and expectations to validation engineers and project team.

7. Represent validation as a subject matter expert (SME) in all project phases (including commissioning and qualification execution).

8. Represent the validation program and designated validation activities during inspection by regulatory agencies and Biogen Quality / Regulatory functions.

9. Review of technical documents / reports to ensure that validation activities are consistent with current company, industry, regulatory requirements, and current technolog y.

Education / Experience

Bachelor of Science Degree (BSc) in an engineering or scientific discipline.

MSc in a related discipline preferred.

10 years experience in a Validation / Quality role in a biopharmaceutical manufacturing environment or equivalent.

Miscellaneous :

  • Thorough knowledge of biotechnological technologies, processes and clean utilities.
  • English is Mandatory
  • Large project experience with Pharma biotech highly appreciated
  • Demonstrated proficiency in Good Practice requirements (GMP, GEP) as well as biopharmaceutical industry regulations and norms as they relate to validation.
  • Strong technical writing and communication skills in English. German an advantage.
  • Proficiency in MS Word, MS Excel and MS Project.
  • If you are interested to learn more about this great opportunity, don’t hesitate to get in touch with me. Feel free to send me your CV at following email

    olivier.worch randstad.ch

    I am looking forward to receiving your applications

    Consultant

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