About the role
We are seeking a Project Engineer to join our clients Inspection team. This role requires technical expertise in inspection equipment and technologies used in pharmaceutical production environments.
The ideal candidate will have experience in testing, verification, and validation of inspection systems within sterile settings. As Project Engineer, you will be responsible for the engineering of specific inspection installations, including visual inspection machines, leak testers, camera and sensor systems, reject handling, and related automation. The role involves providing technical input within the project team, possessing thorough technical and operational knowledge, and understanding the installation's functionality and compliance requirements.
Key responsibilities
- Develop and document technical specifications, including Engineering Design Specifications and P&IDs
- Coordinate with Lead Engineer during design, construction, and implementation phases
- Work according to engineering standards
- Oversee construction, installation, and commissioning to ensure compliance with specifications
- Apply project management tools for planning, budgeting, risk management, and stakeholder engagement
- Manage contractors for the construction, installation, and testing of inspection equipment
- Ensure accurate documentation of construction, verification, and validation activities within the engineering project file
- Define and conduct engineering tests, including the verification and validation of inspection equipment
- Develop validation strategies, test protocols, and verification/validation documents; execute testing procedures and coordinate approvals with Subject Matter Experts (SMEs) and system owners
- Manage and record deviations and corrective actions (CAPAs), perform risk assessments, review compliance with cGMP standards, and update documentation accordingly