Facility and Equipment (Sr) Director / Helmond

Organisatie: Pharming Group
Locatie: Helmond
Functie: Facility and Equipment (Sr) Director
Vervaldatum: 06/07/2021
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Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Facility and Equipment (Sr) Director

About the role:

The F&E (Sr) Director designs and implements the F&E strategy for the growing company, ensures that the right capital investments are made to support the growth, builds the F&E organization and ensures that appropriate resources are in place to ensure that facilities, utilities, automated systems and equipment are commissioned, qualified, revalidated and maintained according to the regulatory expectations

Areas of responsibilities:

  • To ensure that a robust global F&E strategy and organization is developed and implemented to support the growth of Pharming (balanced model of internal resources and external contracts). S(he) is responsible for the facilities related to Operations and R&D
  • To ensure that the right capital investments are made timely to support the growth
  • To lead the group that installs and maintains the facilities, utilities, automated systems and equipment in line with regulatory expectations (e.g. commissioning, qualification, validation, cleaning, security, maintenance, calibration)
  • To approve documents related to CQV/CSV (commissioning qualification, validation and computer systems validation), regulatory submissions, contracts and policies
  • To ensure that facilities, utilities, automated systems and equipment can be used safely (by people and towards the environment)
  • To ensure that Lean principles and risk assessments are used in execution of the strategy
  • Required skills and qualifications in order to be successful in this role:

  • Leadership: encourages others to take action and ensures that employees understand how their results affect the rest of the organization. Strives towards a high level of performance. Ability to build an organization from scratch and create a high performing team
  • Decisiveness: makes timely decisions, even if all information is not available, considering the consequences
  • Persuasiveness: makes his/her point and achieves a positive result with a difficult proposition. States the common interest.
  • Collaboration: actively contributes to a common result or problem solving, even when this cooperation is for a subject that is not of immediate personal interest
  • Excellent verbal and technical writing skills both in English and Dutch, separating main issues from secondary issues and sharing information in a logical order
  • Knowledge:

  • Master’s degree or PhD e.g. Engineering, (Bio)Pharmaceutical Sciences, Life Science & Technology
  • Sound knowledge and understanding facilities, utilities, automated systems, equipment and documentation requirements
  • Very knowledgeable of Current Good Manufacturing Practices (cGMPs) and regulatory guidelines (EMA, FDA, ICH, GAMP)
  • Knowledgeable on lean principles
  • Experience :

  •  Minimal 15 years of relevant working experience in the pharma/biotech industry and minimal 10 years managerial experience
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