Shire Validation Engineer II - Manufacturing Equipment & Clean Utilities in Lessines, Belgium
The Validation Engineer II performs qualification / validation activities linked to his/her part of the business (Manufacturing Equipment, Clean utilities)
He/She prepares and implements the validation documentation required to assure the proper development of a project.
He/She manages deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.
Prepare and implement the validation documentation required to assure the proper development of a project. Act as a validation representative for projects, with support of his/her Validation Supervisor:
Define and implement all validation activities related to the project.
Develop the Validation Plans: define validation methodology and approach in line with the Validation Supervisor.
Provide validation expertise for the development of the project.
Conduct the risk assessment related to the project.
Review the URS, FS, DS and DR.
Prepare the DQ.
Review the commissioning protocols and reports to ensure leveraging into qualification.
Prepare the IQ, OQ & PQ protocols.
Assure requirements traceability throughout the whole project validation file (from URS to PQ).
Organize and coordinate IQ, OQ & PQ validation activities with the different involved departments (on the ground, as required)
Analyze, interpret, document and report the testing results.
Ensure the follow-up and tracking of the validation activities. Update the validation documentation system.
Assure feedback of status and issues to the Validation Supervisor.
Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs, and all aspects of safe, reliable and consistent operation of the system.
Manage deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.
Support junior validation engineers as well as provide day to day guidance for the execution of Validation activities (Depending on applicant’s expertise)
Defend validation topics related to his/her projects during Regulatory Inspection and prepare validation parts of the submission file
Assuring the ability to meet the Department goals in respect to Quality, Finances, Fullfilment and EHS
Minimum Bachelor Degree or equivalent in Engineering, Chemistry, Life Science, or other job related discipline
2 years' experience in Validation/Quality systems
Project management experience
Excellent communication skills, fluency in english
Familia with Quality Management and GxP Regulations
Knowledge of Validation Methodologies
Knowledge of Quality Systems, European and FDA regulations, cGMP, GDP
Knowledge of the manufacturing processes
Excellent analytical skills
Sound industry knowledge, project proficiency, and autonomy expected
In Lessines, Shire is producing drugs for immunological and hematological therapies. The main activity of the site is the purification of plasma immunoglobulins for the treatment of primary immunodeficiency, as well as the treatment and conditioning of coagulation factors for haemorrhagic disorders (haemophilia A and B). As a production site, the Lessines factory operates 24/7 and employs more than 950 people.
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Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.