Shire Validation Manager CSV/UTILITIES in Lessines, Belgium

The CSV-Utilities Validation manager manages resources on site, drives continuous improvement and standardization for Engineering Validation.He is responsible for critical computerized system, facilities and utilities validation. He prepares and implements the validation documentation required to assure the proper development of a project and support regulatory submissions.

The Validation manager implements and maintains current the Global Master Facility Validation Plan (FVMP) to assure that all Computerized Systems, Utilities and Facilities are validated and in an accurate validation state.

Main responsabilities are:

  • Assuring aligned resource management within the Department while taking into account internal User Requirements as well as Quality and GxP guidelines,

  • Contributing to continuous improvement and International standardization for topics related to Computerized System, Utilities and Facilities qualification,

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

  • Managing and developing employees and potential leaders within the Department,

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

His responsibilities are:

Leading, organizing and motivating his team Assuring an adequate organization and team structure Incumbent will schedule, plan and manage validation projects including facility/Utilities and computer-based systems and software improvements, modifications and additions Participate in divisional projects. Responsibilities also include oversight for the development, completion, logging and archiving of documentation on protocols, Validation Master Plans, and Validation Summary Packages. Assure coaching and define specific training requirements of his team, Responsible for assuring development of team members through internal and external training Develop schedules and performance requirements. Coordinates activities of personnel in other departments and contractors as well as providing day to day guidance to the Validation staff. Acts as advisor to subordinates to meet schedules and/or resolve technical problems. May host regulatory agency audits and present validation topics. Assure that EHS aspects are included in validation files. Assure the monitoring and reporting programs to maintain the accurate validation state of critical systems and equipment by implementing the Facility Validation Master Plan (FVMP). Responsible for planning and meeting project CAPEX Budget Responsible for Recruiting & training of team members Training, Development of team members as well as taking disciplinary actions if necessary Review & Approval of critical high level validation documents as appropriate May perform other duties as assigned.

ESSENTIAL RESPONSIBILITIES:

In order of importance, indicate the essential responsibilities of the position and the % of time dedicated to each. (must total 100% - no responsibility should be less than 5%)

Importance

Major Action and Support Actions

% of Time

1.

Support of Validation activities of his team ( review of documents, participation to Project meeting)

50

2

Manage and Develop his team

30

3

Support Validation topics of his area during audit, customer visits

10

4

Support Integration and Training for new employee

10

All other duties as assigned.

Job Scope (Check One):

Country Multiple Countries Region ( US/PR/CANADA LATAM EMEA AP) OUS ITC Global

EDUCATION AND EXPERIENCE (List the MINIMUM education and experience required to perform the essential functions of the position):

Minimum Degree Required:

Master degree

Preferred Degree:

N/A

Certificate(s):

  • No certificate required

Experience:

  • Experience in Validation preferabily CSV: 5 years minimum

  • Experience in pharmaceutical industry or related industry: 10 years minimum

  • Experience in people management: 7 years minimum

KNOWLEDGE, SKILLS AND ABILITY:

(List the MINIMUM knowledge, skills and ability required to perform the essential functions of the position):

  • Project management experience

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

  • Familiar with Quality Management and GxP Regulations

  • Knowledge of Validation Methodologies

  • Sound industry knowledge, project proficiency, and autonomy expected.

LEADERSHIP/SUPERVISORY:

Individual Contributor Manager (Project/Program) Manager (of People)

TRAVEL REQUIREMENTS:

(% of time, Local/Regional/Global)

Not Applicable or: Occasionally - Europe

SCOPE (Revenue, etc.):

N/A

SPAN OF CONTROL:

# of Direct Reports

Between 3 to 7

PRODUCT PORTFOLIO:

Not Applicable or:

SIGNATURE APPROVALS (Name/Title): (based on Authority Matrix)

INCUMBENT (NAME/TITLE/DATE):

MANAGER (NAME/TITLE/DATE):

Baxalta is an equal opportunity employer. Baxalta evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law at http://baxalta.com/assets/documents/eeocselfprint_poster.pdf

EEO is the law GINA Supplement at http://baxalta.com/assets/documents/eeocginasupplement.pdf

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.