9 days old

Project Engineer Quality & Systems


The Pfizer Puurs Engineering department is responsible for the realization of Capital Projects for the production of aseptic drug products, starting from the conceptual design phase up to the full validated operational phase. The Quality & Systems Engineer is member of the Engineering Quality & Systems team. The quality & systems Engineer is responsible for the audit readiness of Engineering and projects related to engineering systems.


1. Degree

+ A 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 and experience as audit spokes person

+ Knowledge of Validation

+ Knowledge of regulatory requirements

4. Specific training and skills

+ Strong organizational skills and structured approach

+ High level of social and communication skills

+ Fluent in Dutch and English


Owner of the audit readiness program engineering

+ Ensure continuous audit readiness of the engineering department

+ Engineering point of contact and representative within the organization

+ Leading 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

+ Coordination and advising role during audits (topics related to the engineering department)

+ Post audit support

+ Support/coordination in defining audit responses and action plans

+ Communication to management concerning the audit readiness status

Support in Engineering related deviations (MIR)

+ Investigation, documentation and follow-up of deviations (MIR) related to engineering projects

Project related to 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).


Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Posted: 2020-10-13 Expires: 2020-11-18

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