Project Engineer Freeze Dry/ALUS/Isolator (Sub Team Lead Vaccine Cell 2 project)
Pfizer
Puurs, Belgium
10 uur geleden
source : OnlyEngineerJobs

Departmental Statement 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.

During the execution phase of the projects, a multi-disciplinary project team is responsible for the detailed design, procurement, construction, commissioning, initial start-up, verification, qualification, validation and start-up of the new operations.

Besides the Project Engineers from the engineering department, the project team also includes project engineers, experts and technicians from product support, operations and operational supporting departments.

The project team is led by a dedicated Project Lead who manages all aspects of the project. For the larger projects, the project team is structured in various disciplinary sub-teams by equipment groups, facilities & utilities, automation & integration, ), led by a Sub Team Lead in full support of and reporting to the overall Project Lead.

This role plays a key part in the project realization of large capital project with both technical and project management guidance ensuring safe, robust, and cost-effective designs and operations while optimizing capital investment.

This role provides connectivity to the end user(s) (operations, support and maintenance) and start-up organization, linking to the wider Pfizer Puurs site structures and organization.

Location for this role is Puurs and might involve occasionally flexible working hours depending on the project execution phase.

The Equipment Sub-Team Lead acts as a project lead’ for his / her equipment’ sub team, being accountable and responsible for all project related matters of his / her equipment’ sub team.

Tasks This role provides input to the project and the Project Lead from a project controlling responsibility (budget, cost, scope, planning, (sub-) project follow-up and reporting, a high safety driven project construction and start-up responsibility and a full cGMP compliant and RFT-driven project quality responsibility.

Actively participates in the overall project organization - member of the project core-team and ad-hoc member of the project coordination and / or steering team.

Sets up and lead the equipment sub team and chair of the sub team meeting(s) Responsible for the daily follow-up of the design, procurement, construction, commissioning, initial start-up, verification, qualification, validation and formal transfer to operations of the related equipment(s) of his / her sub team.

Takes the lead and / or actively participate in the daily project DOR-meeting during construction, initial start-up, testing up until full hand-over to operations.

Takes the lead and / or actively participate in any project safety incident investigation (first aids, near miss, TIR, ) or project quality related issues or investigations (SCHOK, CAPA, QAR, MIR, ) occurring during the project execution.

Actively promotes close collaboration between the sub team members, with other sub teams and striving for highest teamwork performance of the sub team.

Fosters and ensures the site’s capital project management process (CPMP) workflow in projects within the sub team Communicates proactively with the Project Lead regarding activities, progress, issues, risks, actions, mitigation plans, Qualifications Required experience : Master degree in Engineering or scientific related qualification or significant experience in Pharmaceutical / Aseptic Manufacturing operations A minimum of 5 years in the pharma (asceptic) industry Knowledge of and experience in Validation Knowledge of freeze dryers, and / or automatic loading systems (ALUS) and / or isolators is a plus Process and / or equipment knowledge and experience of aseptic manufacturing Knowledge of cGMP and GEP Knowledge and / or experience in project management or execution Knowledge of larger capital project design and execution and knowledge of the site’s capital governance structures Experience within a continuous manufacturing environment in a regulated industry is a strong advantage Required skills : Good analytical and problem solving skills Good social, communication, networking & stakeholder management skills Good project & operational management skills Good knowledge of MS Office Fluent in Dutch and English Good understanding of French & German Safety and quality minded Ability to lead a (sub-)team of a highly educated technical engineers, experts, technicians The successful candidate is expected to continue to develop skills to grow towards the role of overall Project Lead.

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

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