General information

Validation Engineer
HAL Allergy is searching for a Validation Engineer to support the validation of the cleaning- and sterilization processes in our multi-product GMP facility.
Tasks and Responsibilities
  • Maintains the validated state of cleaning and sterilization processes and procedures;
  • Maintains the site cleaning (and sterilization) validation master plan and supports the periodic review of the cleaning (and sterilization) validation program;
  • Conducts risk assessments of existing and new processes, equipment, etc. related to cleaning or sterilization procedures and validation;
  • Designs cleaning (manual or automatic) and sterilization processes for new products and equipment, and develops procedures;
  • Designs cleaning/sterilization validation studies, prepares protocols and reports and executes the validation studies;
  • Assesses (major) deviations and changes related to cleaning and/or sterilization procedures for impact on product quality. Takes ownership of subsequent CAPAs;
  • Manages, schedules, coordinates, and executes engineering studies to optimize procedures and validation/verification studies;
  • Issues Change Controls for implementation of (new) cleaning and/or sterilization processes or changes to existing procedure;
  • Provides technical support to cleaning activities associated with the manufacturing process;Trains Manufacturing and QC personnel on cleaning/sterilization validation protocols and procedures.
Requirements
  • Minimum BSc degree in Life Sciences with a minimum of five years of relevant experience in the pharmaceutical industry;
  • Solid experience in validation of cleaning and sterilization processes for (bio-)pharmaceutical products; 
  • Experience with risk assessment and change management;
  • Good knowledge of GMP and relevant pharmaceutical regulatory guidelines;
  • Proficient in Dutch and English (spoken and written).
Personal & Professional Skills

You are a result oriented professional with the ability to work on different types of projects. You can communicate and cooperate well with different stakeholders of various levels. With different projects and deadlines ongoing, you are able to plan and prioritize your own work.

Offer
  • We offer you a highly dynamic job in an interesting environment.
  • You will be working from our headquarters in Leiden, where the products are produced on site.
  • HAL Allergy offers great benefits including a competitive salary, 13th month, 30 holidays, contribution to pension and health insurance.
Applications and more information
Interested? We look forward to receiving your application. To apply, please click the "Apply" button below to the right where you will be prompted to upload your CV first. 
Company Information

HAL Allergy is a modern leader in the field of biopharmaceuticals, located in the Leiden Bio Science Park in The Netherlands. Our core business is the development and manufacturing of therapies and diagnostics for allergic diseases.

 

With offices in major European countries, HAL Allergy is one of the European top players in the allergy immunotherapy business. Established in 1959 HAL Allergy has a long experience in developing, producing and selling allergy therapies with an immuno-modulatory effect, resulting in a reduction of symptoms and long-term disease suppression. These therapies are primarily used against common allergies such as hay fever, house dust mites allergy and allergic reactions towards wasp or bee stings.

 

We employ around 300 highly specialized people across various functions. The departments at our headquarters include Research & Development, Production, Quality Assurance, Clinical Development and Regulatory Affairs. Our staff works closely together with leading research institutes. At our locations in Germany, Poland, Austria, Spain and Italy we mainly focus on service and sales activities.

 

We are a steadily growing and dynamic company with a culture that is characterized by entrepreneurial spirit and a friendly and helpful atmosphere. The patient’s well-being is always our top priority. This combination is the basis for an interesting and challenging environment.

 

In addition to the core business of HAL Allergy, our subsidiary HALIX was founded in 2012. HALIX is a contract development and manufacturing organization (CDMO) licensed for the contract manufacturing of clinical and commercial medicines according to GMP standards. As an end‑to‑end service provider, HALIX will serve its customers the full range from the first development steps to start of commercial production after successful registration of products.