Key Skills

Job Description

We are looking for a Project Engineer for our client, a global biopharmaceutical company based in Haarlem, Netherlands, who will support and manage small-to-medium-sized pharmaceutical packaging projects, including equipment upgrades and improvements within a GMP-regulated environment. A Process or Mechanical Engineering background is preferred. The role will involve coordinating project activities, collaborating with cross-functional teams, and supporting the preparation and execution of CQV documentation and change control. The initial contract duration is 12 months, with the potential to extend. Responsibilities: Manage small-to-medium-sized packaging projects from planning through to implementation and handover. Develop and maintain project plans, schedules, milestones, deliverables and action lists in collaboration with relevant stakeholders. Coordinate project activities with Engineering, Manufacturing, Quality, Validation, Maintenance and external suppliers. Monitor project progress, identify risks or obstacles, and support appropriate mitigation actions to maintain the project programme. Understand the preparation, review and execution of Commissioning, Qualification and Validation (CQV) documentation for packaging equipment and associated project changes. Support the coordination and completion of CQV deliverables in accordance with site procedures and GMP requirements. Support change control activities associated with equipment upgrades, modifications and project implementation, ensuring required assessments, approvals and documentation are completed. Coordinate equipment vendors, trade contractors and internal project team members to ensure work is completed safely and in line with project requirements. Act as a point of contact between relevant departments to support effective communication and alignment on project objectives. Maintain accurate project records, technical documentation, schedules and progress reports. Support project close-out and handover, ensuring outstanding actions and required documentation are completed. Qualifications & Experience: Bachelor's degree in Mechanical Engineering, Process Engineering or a relevant engineering discipline. Experience supporting or managing engineering projects within the pharmaceutical, biopharmaceutical or other GMP-regulated industries. Experience with small-to-medium-sized projects, preferably involving pharmaceutical packaging equipment, packaging lines or equipment upgrades. Understanding of preparing and executing CQV documentation and commissioning and qualification activities. Understanding of change control processes and GMP documentation requirements. Strong project coordination, organisational, communication and problem-solving skills. Ability to coordinate multiple activities and work effectively with cross-functional teams and external suppliers.

Core Responsibilities

Manage small-to-medium pharmaceutical packaging projects from planning through implementation and handover, coordinating internal teams, suppliers, schedules, risks, and project documentation. Support CQV and change control activities for packaging equipment upgrades while ensuring work and deliverables meet site procedures and GMP requirements.

Requirements

A bachelor's degree in Mechanical Engineering, Process Engineering, or a relevant engineering discipline is required, along with experience supporting or managing projects in pharmaceutical, biopharmaceutical, or other GMP-regulated industries. Candidates should understand packaging equipment projects, CQV activities, change control, and GMP documentation, and have strong coordination, communication, organizational, and problem-solving skills.