Process Calibration and Validation Technician| Brussels


Function: Process Calibration and Validation Technician

Reports to the Supervisor Maintenance (hierarchical)

Reports to the engineer Maintenance Calibration & Validation (functional)

Objectives:

Plan and execute calibrations and validations, including reference standards according to GMP guidelines and internal procedures to ensure equipment operates within predefined acceptance criteria and under controlled conditions at Neder-Over-Heembeek as well as Buggenhout.

Key responsibilities and areas of result:

1. Calibration: 

  • Plan and execute calibrations in agreement with the users based on the Calibration Year Plan, following GMP guidelines and internal procedures to ensure equipment operates within predefined acceptance criteria and under controlled conditions at Neder-Over-Heembeek as well as Buggenhout.
  • Test, document and adjust when required to ensure equipment meets the acceptance criteria
  • Reporting of the results according to standard operating procedures
  • Document results in SAP
  • Report non-conformities to the engineer, in order to determine the impact on products within the Quality system
  • Assist other departments with measuring and reporting of calibrations
  • Eg. Standard calibrations of pressure sensors, temperature sensors, scales, …

2. Validations: 

  • Plan and execute periodic validations, based on the Validation Year Plan and following GMP guidelines and internal procedures (SOP) to ensure equipment and systems remain in a validated state:
  • Execute validations: mainly thermal mapping of freezers, cold rooms, …
  • Document validations in logbooks or SAP
  • Evaluation and reporting of results
  • Assistance to other departments for programming and readout of temperature loggers and reporting of validations

3. Analysis and reporting: 

  • Analyse, interprete and (accurate and punctual) reporting of data and results, according to the procedure and corresponding templates to ensure timely escalation of problems and taking actions:
  • Analysis and interpretation of results
  • Discuss and consult calibration/validation results
  • Draft calibration and validation reports based on a template or protocol

4. Follow up of reference equipment: 

  • Verification, follow up, re-program, order and replace calibration equipment, validation equipment to ensure the availability of the equipment
  • Propose alternatives to replace equipment
  • Requesting quotes for calibration and validation equipment
  • Purchase of reference equipment from external calibration companies

5. Optimisation: 

  • Propose new methodologies to calibrate new equipment, as well as new calibration procedures and after approval, create/update working instructions
  • Create new work instructions for existing or new equipment
  • Propose improvement on current work instructions, validation & calibration procedures

6. Other activities: 

  • Proactive or at request of the line manager to support the Maintenance or other departments.
  • Repair/replace broken instruments in production
  • Follow up external contractors during execution of calibrations and validations

7. You could be available for guard duty (24 hours a day, 7 days a week)


Profile:

  • You are in possession of a bachelor degree (Electrical, mechanical or eletromechanical) or equivalent by experience
  • You ideally have initial experience in a similar position (experience within the pharmaceutical/biotech sector is an asset)
  • You preferably have knowledge of quality systems and European and American GMP guidelines
  • (Good Manufacturing Practices) and SOPs (Standard Operating Procedures).
  • You are familiar with MS Office package and other software packages (knowledge of SAP is an asset)You are Dutch- or French-speaking, you can express yourself in the other language and you have a solid knowledge of English
  • You are meticulous and quality oriented;
  • You take a systematic approach and can set priorities;
  • You are flexible and willing to participate in the guard system.


Our Company

Prothya Biosolutions produces plasma preparations (including known products such as Cofact, Nanogam and Albuman). In addition, Prothya collects, tests and supplies blood plasma to purification and production sites worldwide. Prothya Biosolutions’ mission is to provide healthcare organizations worldwide with high-quality plasma products. The company does this by creating value for partners and contributing to the health of people who depend on essential plasma proteins. Hence, Prothya’s slogan: Creating Value, Sustaining Life. The company has various office and production locations in the Netherlands and Belgium and employs around 1,000 people. 

We offer

Prothya Biosolutions BE is part of an international biopharmaceutical group which offers long-term career perspectives and invests actively in on-the-job training.

In return for your performance, you shall receive a competitive salary, group and health insurance, meal vouchers, and eco-cheques, as well as a Flex Reward Plan. The Flex Reward Plan is a flexible compensation system through which employees can create a budget from their current salary components. Thanks to this plan, they can enjoy, on a voluntary basis and according to their personal choice, a series of benefits that Prothya Biosolutions BE offers once a year.

We also offer an attractive holiday system exceeding the legal holidays.

Furthermore, we value mutual respect and diversity is our strength.

For each Prothya Biosolutions BE employee, from operators to the CEO, engagement means showing initiative. We expect all colleagues to contribute to achieving our annual objectives in order to take the organization towards it future challenges and successes.

Are you interested? Send your CV and covering letter.

Apply Now