Project Engineer

TPM6141; Haarlem; On-site; EUR 60,000 - 80,000; Full time

Job summary

A Project Engineer is sought for a global biopharmaceutical company in Haarlem, Netherlands, to support and manage small-to-medium-sized pharmaceutical packaging projects, including equipment upgrades and improvements within a GMP environment. A Process or Mechanical Engineering background is preferred.

You will coordinate activities with Engineering, Manufacturing, Quality, Validation, Maintenance and external suppliers; assist CQV documentation and change control, and ensure project records

Qualifications

• Bachelor’s degree in Mechanical Engineering or Process Engineering.
• Experience supporting or managing engineering projects in GMP-regulated industries.
• Experience with packaging equipment or packaging lines.
• Understanding of CQV documentation and commissioning/qualification activities.
• Understanding of change control and GMP documentation requirements.
• Strong project coordination and cross-functional collaboration skills.
• Ability to coordinate multiple activities with external suppliers.

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 mitigation actions to maintain the project programme.
• Understand the preparation, review and execution of CQV documentation for packaging equipment and related project changes.
• Support coordination and completion of CQV deliverables in line with GMP requirements.
• Support change control activities for equipment upgrades, modifications and project implementation, ensuring approvals and documentation are completed.
• Coordinate equipment vendors, trade contractors and internal project team members to ensure safe work.
• Act as a point of contact between departments to support effective communication on project objectives.
• Maintain accurate project records, technical documentation, schedules and progress reports.
• Support project close-out and handover, ensuring outstanding actions and documentation.

Skills

Project coordination

Organisational skills

Communication

Problem solving

Education

Mechanical Engineering

Process Engineering

Job description

Summary:

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.