Takeda Pharmaceutical Company Ltd. Process Validation Specialist in Lessines, Belgium

Role:

The Process Validation Specialist manages medium to big projects for Process and Cleaning Validation. He/She prepares and implements the validation documentation required to assure the proper development of a project and support regulatory submissions. He manages deviations and changes in order to guarantee that these are well documented and that corrective actions are taken and followed-up upon.

Responsibilities:

  • Contributing to continuous improvement and International standardization for topics related to process and cleaning validation,

  • Supporting small, mid size and big projects within the plant,

  • Assuring the ability to meet the Department goals in respect to Quality, Fullfilment and EHS

  • Take part in internal/external audits.

  • Coordinate activities of junior validation engineers and contractors

Profile:

  • BS Degree or equivalent in Engineering, Chemistry, Life Science, or other job related discipline

  • Minimum 2 years in Validation/Quality Systems in a pharmaceutical industry

  • Project management experience

  • Excellent communication skills, fluent in English and French (written and spoken)

  • Familiar 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

  • Requires excellent analytical skills with systematic approaches to problem solving.Must be able to break down complex problems and tasks into activities capable of being performed by personnel.

  • Sound industry knowledge, project proficiency, and autonomy expected. May be considered a Subject Matter Expert (SME) in various disciplines.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.