Process Validation Specialist

  • Location: NEDER-OVER-HEEMBEEK
  • Type: Perm
  • Job #15469

Process Validation Specialist

Bruxelles Nord – CDI

#Process #validation #job #specialist

You have a first experience in pharmaceutical company? You are an efficient person? You can handle different projects simultaneously owing to your organizational skills? Keep reading your future job description.

Our partner is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products.  With over 80 years serving the industry, our partner has proven expertise in providing development, production and packaging services for pharmaceutical and biotech companies.

For the sterile production site located in Belgium in Brussels (Neder-Over-Heembeek) which is currently expanding its capabilities, we are currently looking for a Process Validation Specialist:  you will act as an expert for the validation of processes and support in QbD assessments (Quality by Design). You will also be involved in other activities, related to the process (cleaning, MFT) and to the manufacturing equipment’s (qualification). The Process Validation Specialist reports to the Qualification & Validation Aseptic Leader

 

What are your responsibilities?

To be successful as Process validation Specialist, here are your tasks:

  • Ensure that all qualifications and validations are performed according to the regulatory and customer requirements
  • Be able to support Quality by Design on the drugs to be transferred or developed on the site
  • Write qualification and validation protocols/reports and other documentation related to the activities
  • Based on the deduced CQAs (Critical Quality Attributes) and CPPs (Critical Process Parameters) be able to develop the appropriate validation plan
  • Be an expert for the validation of aseptic process (formulation, filling, holding times)
  • Participate to shutdown qualification & calibration activities
  • Investigate deviations as needed and execute corrections
  • Define and execute improvement projects and initiatives
  • Participate in customer and authority audits
  • Can be involved in other process validation activities
  • Ensure that all activities are performed in time and due quality

 

 

Who are you?

  • Minimum of 3 years of experience in the pharmaceutical industry, with 3 years in a validation role or a similar position
  • Experience in Quality by Design is an asset
  • Maturity in the role
  • Integrity
  • Positive energy and mind-set
  • Excellent communication skills are desirable
  • Fluency in French and English is required

What can you expect?

  • What we offer is an exciting role, a chance to grow and learn new skills in a global company, and in the most challenging quality environment within the pharma industry – a sterile business
  • Potential for personal development within an international company
  • Defined career path and annual performance review and feedback process
  • Contributory pension and benefits package all offered from day one of employment
  • 36 days’ holiday + bank holidays

 

You’re interested in this job? We kindly invite you to apply directly on our website. Do you have questions? You can contact Dimitri Soupart : [email protected]

 

 

Process Validation Expert

  • Location: NEDER-OVER-HEEMBEEK
  • Type: Perm
  • Job #15470

Process Validation Expert

Bruxelles Nord – CDI

#Process #validation #job #expert

You have a first experience in pharmaceutical company? You are an efficient person? You can handle different projects simultaneously owing to your organizational skills? Keep reading your future job description.

Our partner is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products.  With over 80 years serving the industry, our partner has proven expertise in providing development, production and packaging services for pharmaceutical and biotech companies.

For the sterile production site located in Belgium in Brussels (Neder-Over-Heembeek) which is currently expanding its capabilities, we are currently looking for a Process Validation Expert. The Process Validation Expert is responsible for coordinating all process validation activities related to the development or the technical transfer of Drug Product manufacturing, while providing adequate customer service. She/he works in close collaboration with other groups as Operations, Product Development, MS&T (Manufacturing Science & Technology) and Project Management Office.

As an expert for the validation of processes, she or he ensures appropriate Quality by Design approach for the manufacturing processes of a wide variety of products. She/he will also support other activities, related to current operations (e.g. equipment cleaning, sterilization etc.).

The Process Validation Expert reports to the Process Validation Manager.  

 If you would like to be part of a global drug development and delivery leader, then this role might be for you!

 

What are your responsibilities?

To be successful as Process validation Expert, here are your tasks:

  • Be able to manage appropriately a Quality by Design approach on the drugs to be transferred or developed on the site;
  • Based on the deduced CQAs (Critical Quality Attributes) and CPPs (Critical Process Parameters) be able to develop the needed process validation plan;
  • Ensure that all validations are performed according to the regulatory, site and customer requirements;
  • Be an expert for the validation of aseptic process (formulation, filling, filtration, holding times etc.)
  • Ensure that all activities are performed in time and with due quality;
  • Author validation documentation including, but not limited to, Process Validation protocols and reports, Cleaning Validation protocols and reports, and Protocol Discrepancies and Addenda.
  • Investigate deviations as per need and execute corrections and/or develop preventive actions;
  • Define and execute improvement projects and initiatives in order to improve process validation and customer/site support;
  • Participate in customer and regulatory audits;
  • Participate to shutdown activities (e.g. air visualization tests);
  • Can be involved in other process validation activities.
  • Can be involved in other process validation activities
  • Ensure that all activities are performed in time and due quality

 

 

Who are you?

  • Minimum of 5 years of experience in the pharmaceutical industry, wherein a minimum of 2 years of experience in a sterile production environment is considered a must
  • Minimum of 2 years’ experience in a process validation role
  • Fluency English is required
  • Being able to communicate in French is needed
  • Experience in QbD is a must
  • Maturity in the role, Quality oriented, Integrity, Positive energy and mind-set and excellent communication skills are desirable

What can you expect?

  • What we offer is an exciting role, a chance to grow and learn new skills in a global company, and in the most challenging quality environment within the pharma industry – a sterile business
  • Potential for personal development within an international company

 

You’re interested in this job? We kindly invite you to apply directly on our website. Do you have questions? You can contact Dimitri Soupart : [email protected]