Project Engineer Quality & Systems

Pfizer Inc.

Puurs, Belgium

Job posting number: #7150820 (Ref:pf-4885965)

Posted: May 26, 2023

Application Deadline: Open Until Filled

Job Description


    This function is accountable for:

    • coordination of validation activities in capital projects
    • scheduling capital project activities related to Quality Systems and Engineering Systems
    • point of contact validation coordination and planning


    1. Degree

    • Master degree

    2. Formal education

    • Scientific discipline (Engineering, Bio-engineering, Pharmacy, …)

    3. Experience required

    • Minimum of 3 years of experience in the pharmaceutical industry
    • Knowledge of and experience in Validation
    • Knowledge of and experience in Scheduling and MS Project
    • Knowledge of and experience in Quality Management Systems
    • Experience with at least one other Engineering System: Technology Management, Project Management, Good Engineering Practices, Testing and/or Contractor Management.

    4. Specific training and skills

    • Strong organizational skills and structured approach
    • High level of social, communication and coaching skills
    • Capable to maintain a good overview while diving into details when needed
    • Knowledge of PC applications Word – Excel – Powerpoint – Sharepoint – MS Projects
    • Fluent in Dutch and English


    Coordination of validation and planning activities

    • Supports the project lead in coordinating the project team to achieve the defined project deliverables in relation to validation.
      • Composes and consolidates the overall validation project plan/report and clarifies the validation strategy to the project team, management and inspectors.
      • Continuously follows up the predefined validation strategy, adjusts and/or escalates if needed and provides overview of the status and potential impact on project timeline.
      • Coaches the project engineers related to validation and quality systems and watches over good validation practices and the quality of the different deliverables.
      • Facilitates and documents quality risk assessment activities.
      • Provides input for management communication & reporting.
      • Bridges between Engineering, Site Compliance, SME’s and System Owners.
    • Supports the project lead in coordinating the project team to achieve the defined project time line.
      • Composes, consolidates and maintains the project schedule file in MS Project.
      • Monitors continuously the project schedule file and keeps the project team informed regarding the progress and alerts problems/conflicts relating to the execution of project tasks and activities.
      • Assists the project lead to define, evaluate and document project risks and mitigation plan.
    • Provides input for management communication & reporting.

    Supporting ownership of audit readiness program engineering

    • Supporting role in the audit preparation of planned inspections
      • Communication
      • Preparation of the inspection tour (focus on construction zones and Engineering projects)
      • Follow-up construction area audit readiness
      • Follow up availability engineering spokes persons
      • Preparation pre requests inspections
    • Post audit support
      • Support/coordination in defining audit responses and action plans
    • Acts as back-up for the owner of the audit readiness program in engineering

    Supporting process ownership of Quality and Engineering Systems

    • Responsible for the initiation,  planning and execution of projects related to Quality Systems (Systems Validation, CRF, MIR, CAPA, …).
    • Responsible for the initiation, planning and execution of projects related to Engineering Systems (Technology Management, Good Engineering Practices, Testing and Contractor Management).
    • Acts as Engineering representative in process teams related to Quality Systems (change management, verification, validation, …).
    • Investigation, documentation and follow-up of deviations (MIR) related to engineering projects
    • Acts as back-up for the process owner Systems Validation.
Work Location Assignment: Flexible

De Pfizer site in Puurs is één van de grootste productie- en verpakkingssites van Pfizer wereldwijd, gespecialiseerd in aseptische productie en verpakking. Jaarlijks worden in Puurs meer dan 400 miljoen doses injecteerbare vaccins en medicijnen geproduceerd. Deze zijn ter plaatse verpakt in ampullen, flacons, plastic flessen, spuiten en patronen voor pennen. 


De medicijnen die in Puurs worden gemaakt, zijn bestemd voor patiënten in meer dan 170 landen wereldwijd. 30% van de productie uit Puurs is bestemd voor ontwikkelingslanden, in samenwerking met UNICEF, WHO, GAVI en ngo's. 

Met het gebruik van twee windturbines, zonnepanelen en een warmtekrachtcentrale richten we ons op hernieuwbare energie. 


Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

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More Info

Job posting number:#7150820 (Ref:pf-4885965)
Application Deadline:Open Until Filled
Employer Location:Pfizer Inc.
New York,New York
United States
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