JOB SUMMARY
The Project Engineer – Pharmaceutical Plant is responsible for the technical planning, design, and execution of engineering projects that support pharmaceutical manufacturing operations. The Project Engineer coordinates with cross-functional teams to deliver capital improvements, facility upgrades, equipment installations, and process optimization initiatives, ensuring compliance with cGMP, safety, and regulatory requirements.
MAIN RESPONSIBILITIES
Plan, organize, and manage engineering projects related to pharmaceutical manufacturing facilities, including new equipment installation, facility modifications, process improvements, and utility systems upgrades.
Prepare project scopes, cost estimates, technical specifications, schedules, and resource plans in alignment with business objectives.
Lead or support the design, procurement, installation, commissioning, and qualification (IQ/OQ/PQ) of equipment and systems in compliance with cGMP and safety standards.
Collaborate with manufacturing, quality assurance, validation, EHS, and maintenance teams to ensure seamless project execution and handover.
Coordinate and supervise contractors, vendors, and third-party service providers to ensure project deliverables meet technical and regulatory requirements.
Conduct risk assessments, support root cause analysis, and contribute to problem-solving initiatives.
Maintain comprehensive project documentation, including technical drawings, change controls, validation protocols, and qualification reports.
Manage project budgets, monitor expenses, and track project progress against schedules and milestones.
Support regulatory audits and inspections by ensuring engineering solutions and documentation meet all relevant quality and compliance standards.
Drive continuous improvement efforts in equipment, processes, and engineering practices.
EDUCATION/QUALIFICATIONS
Bachelor’s degree in Engineering (mechanical, chemical, process, or related discipline).
2+ years of experience in engineering projects within the pharmaceutical, biotechnology, or regulated manufacturing environment.
Strong technical knowledge of pharmaceutical manufacturing processes, cGMP, and regulatory requirements.
Experience with commissioning, qualification, and validation (CQV) of equipment and utilities is an asset.
Proficient with engineering design tools, project management methodologies, and MS Office Suite.
Proven ability to manage multiple projects and priorities in a fast-paced, regulated environment.
Strong analytical, organizational, and communication skills.
Knowledge of health, safety, and environmental regulations.
Ability to work effectively with cross-functional teams and external vendors.
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