Shire Site Lead, Engineering Validation - Lessines in Lessines (Baxalta), Belgium

Managing Resources on site, driving continuous improvement and standardization for global Validation activities. Global Validation is responsible for Validation of Equipment, GMP computer system, Facilities, critical Utilities, lab equipment (non-bench top) validation as well as Validation of Sterilization, Cleaning and Manufacturing Processes (PPQ), Material Qualification (MQ).

ESSENTIAL RESPONSIBILITIES:

  1. Represent Department in regular Site and Global Meetings (incl. projects reviews and meetings)

  2. Manage and Develop Employees (1:1, Dept. Meetings, personal feedback, …)

  3. Regular Meetings and Communications with Site Customers, Interfaces for alignment, improvements

  4. Tasks to drive improvement projects within department and global projects

  5. Review and Reporting of key numbers, regular reports for department (Financial, Fulfillment, …)

  6. Support during Audits, Customer visits, …

Minimum Degree Required:

Secondary, tertiary Education / Degree

Preferred Degree:

University Degree Engineering, Chemistry or Biologic

Certificate(s):

  • Not applicable

Experience:

  • Minimum 10 years experience in pharmaceutical, biotechnology, or related industry.

KNOWLEDGE, SKILLS AND ABILITY:

  • Requires a proven track record of staff management, setting validation policy, working closely with a senior management team

  • Must have respect for individuals and the diverse contributions of all

  • Project management experience

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

  • familiar with Quality Management and GxP Regulations

  • 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.

  • Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage, and conviction.

  • Must have passion to innovate and drive for solutions.

  • Must display personal accountability for results and integrity.

  • Must display eagerness to learn and continuously improve.

  • Must have uncompromising dedication to quality.

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’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire 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 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.

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.