Project Lead Engineer

SIRE LIFE SCIENCES; Leiden; On-site; EUR 90,000 - 130,000; Full time

Job summary

SIRE LIFE SCIENCES in Leiden, Netherlands, seeks a Senior Project Engineer – Project Lead to drive medium complexity capital investment projects from feasibility to closure. You will lead cross-disciplinary teams, manage schedules and budgets, and ensure compliance with GXP and Change Control requirements.

Ideal candidates have engineering and project leadership experience, strong communication, and stakeholder management skills, with proficiency in SAP and Microsoft Office.

Qualifications

• Bachelor's degree in Engineering or related discipline.
• 5–7 years in engineering and project management.
• FPX Project Lead Training certification.
• Experience leading capital investment projects in regulated industry.
• Strong knowledge of engineering design and project execution.
• Familiarity with GXP, Change Control and MoC processes.
• Excellent verbal and written communication.
• Strong stakeholder management and leadership.
• Proficiency with Microsoft Office and SAP.
• Able to work independently with minimal supervision.
• Capable of managing multiple priorities and tight deadlines.

Responsibilities

• Lead medium complexity capital investment projects from feasibility through project closure.
• Develop and manage project schedules, milestones, and deliverables.
• Support project sponsors in defining business needs and project solutions.
• Define and manage project objectives, scope, budgets, timelines, and resources.
• Ensure accurate documentation of project activities and deliverables.
• Ensure compliance with GXP requirements and project governance standards.
• Build, lead, and motivate cross functional project teams.
• Communicate project progress, risks, and key decisions to sponsors and stakeholders.
• Manage supplier contracts, purchase orders, and project-related expenditures.
• Continuously develop technical and professional knowledge through training, industry events, and networking.

Skills

Leadership

Stakeholder management

Communication skills

Analytical thinking

Time management

Education

Bachelor's degree in Engineering

FPX Project Lead Training

Tools

SAP

Microsoft Office

Job description

The Company

A leading global life sciences and biopharmaceutical organization focused on developing and manufacturing innovative therapies that improve patient outcomes worldwide. The company operates in a highly regulated environment and invests heavily in engineering excellence, operational efficiency, and facility modernization.

About the Role

We are seeking a highly motivated Senior Project Engineer – Project Lead to lead medium complexity capital investment projects while providing multidisciplinary engineering expertise. This position plays a critical role in driving projects from feasibility through completion, ensuring compliance with regulatory requirements, engineering standards, budget expectations, and project timelines. The role combines technical leadership, stakeholder management, and project execution within a complex manufacturing environment.

Responsibilities

Lead Engineer Responsibilities

• Act as Core Team Member on medium to high complexity projects, representing all engineering disciplines
• Coordinate the complete engineering scope with internal and external engineering stakeholders
• Provide technical support during project planning, development, implementation, and modification activities
• Exercise independent engineering judgment and evaluate technical alternatives and solutions
• Conduct complex engineering studies, investigations, and design reviews
• Translate project scope into Request for Quotation packages for suppliers and contractors
• Ensure compliance with applicable GXP requirements, including Change Control processes
• Review and approve engineering drawings, calculations, specifications, and design documentation
• Verify designs comply with Dutch, European, and internal engineering standards
• Manage engineering quality and progress delivered by external engineering partners and contractors
• Coordinate facility and process modifications with stakeholders
• Participate in Management of Change activities to ensure proper implementation

Project Lead Responsibilities

• Lead medium complexity capital investment projects from feasibility through project closure
• Develop and manage project schedules, milestones, and deliverables
• Support project sponsors in defining business needs and project solutions
• Define and manage project objectives, scope, budgets, timelines, and resources
• Ensure accurate documentation of project activities and deliverables
• Ensure compliance with GXP requirements and project governance standards
• Build, lead, and motivate cross functional project teams
• Communicate project progress, risks, and key decisions to sponsors and stakeholders
• Manage expectations regarding safety, quality, reliability, budget, and schedule performance
• Manage supplier contracts, purchase orders, and project-related expenditures
• Continuously develop technical and professional knowledge through training, industry events, and networking

Requirements

• Bachelor's Degree, University Degree, or equivalent qualification in Engineering or a related technical discipline
• 5 to 7 years of engineering and project management experience
• FPX Project Lead Training certification or equivalent project leadership training
• Experience leading capital investment projects within a regulated industry
• Strong understanding of engineering design, project execution, and facility modifications
• Knowledge of GXP requirements, Change Control, and Management of Change processes
• Excellent verbal and written communication skills
• Strong stakeholder management and leadership capabilities
• Proficiency with Microsoft Office and SAP
• Strong analytical and problem solving skills
• Ability to work independently with minimal supervision
• Demonstrated ability to manage multiple priorities and tight deadlines