Job Description
Role Overview
The Project Engineer (Commissioning & Qualification) will play a critical role in supporting construction, startup, commissioning, and qualification activities across equipment, utilities, and clean room systems for biologics manufacturing. This position requires hands-on involvement in construction teams, system startup, and compliance with GMP and regulatory standards.
Key Responsibilities
General C&Q Responsibilities
Participate in construction and startup planning for equipment and facilities.
Conduct P&ID walkdowns, Pre-Startup Safety Reviews (PSSR), and punchlist identification.
Collaborate with quality teams to raise and manage change controls.
Execute commissioning, shakedown, and system startup activities.
Configure and validate automation systems (e.g., DeltaV recipes) and transition equipment into functional mode.
Establish operating parameters and ensure alignment with process procedures.
Ensure compliance with GMP requirements an...
The Project Engineer (Commissioning & Qualification) will play a critical role in supporting construction, startup, commissioning, and qualification activities across equipment, utilities, and clean room systems for biologics manufacturing. This position requires hands-on involvement in construction teams, system startup, and compliance with GMP and regulatory standards.
Key Responsibilities
General C&Q Responsibilities
Participate in construction and startup planning for equipment and facilities.
Conduct P&ID walkdowns, Pre-Startup Safety Reviews (PSSR), and punchlist identification.
Collaborate with quality teams to raise and manage change controls.
Execute commissioning, shakedown, and system startup activities.
Configure and validate automation systems (e.g., DeltaV recipes) and transition equipment into functional mode.
Establish operating parameters and ensure alignment with process procedures.
Ensure compliance with GMP requirements an...
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