Project Lead, Engineering, Quality Engineering

For a leading pharmaceutical company in Leiden, we are looking for a Sr. Project Engineer / Project Lead to manage and deliver capital investment projects within a GMP-regulated manufacturing environment.

Details

Starting with a 1 year contract

Start ASAP

Acts as Core Team Member in medium/high complexity projects, representing all engineering disciplines and coordinating the complete engineering scope with other involved engineers.

Provides technical support for project planning, development, implementation, and modification.

Exercises independent judgment on significant details of work and makes selections and adaptations of engineering alternatives.

Performs work involving complex conventional plans, investigations, surveys, structures, or equipment with highly complex features for which there may be no precedents.

Performs applicable GxP requirements (e.g. Change Control).

Checks and approves drawings and calculations for design or construction and verifies compliance with Dutch, European, and Janssen Biologics standards.

Manages progress and quality with external engineering firms, on-site contractors, and internal stakeholders.

Coordinates modifications with stakeholders and participates in Management of Change to ensure proper implementation.

Manages medium-complexity capital investment projects according to the Engineering Process, from feasibility through project closure.

Develops timelines, oversees activities for the entire project team, and takes responsibility for project completion.

Supports the sponsor in defining the business need and business solution.

Defines and manages project objectives, scope, budget, and timelines.

Ensures proper documentation of project activities and deliverables.

Ensures project implementation meets all applicable GxP requirements (e.g. Change Control).

Builds and leads cross-functional project teams (internal and external to engineering) to achieve project objectives.

Communicates project progress to sponsors and stakeholders, both in person and through portfolio management systems.

Manages client expectations regarding safety, quality, reliability, timing, and budget.

Manages project contracts and purchase orders.

Maintains professional and technical knowledge through seminars, trade shows, professional publications, trend analysis, and networking.

Minimum Qualifications

University/Bachelor's Degree or equivalent.

5 to 7 years of work experience.

Trained in FPX Project Lead Training.

Excellent verbal and written communication skills, including the ability to communicate effectively with internal and external customers.

Excellent computer skills, including MS Office and SAP.

Strong analytical skills to identify gaps and root causes, and develop effective solutions.

Ability to work independently with minimal supervision while meeting tight deadlines and maintaining a positive attitude.

Other Requirements

VCA-VOL Qualification (Diploma).