Project Engineer

Job purpose

Project management and execution

• Lead capital and expense projects from concept through commissioning and handover.
• Develop scopes, schedules, cost estimates, URS, and execution plans.
• Manage contractors, vendors, and internal resources; track project progress, risks, and budgets; communicate status.

Compliance and asset lifecycle

• Support change controls, deviations, CAPAs, quality records, and equipment qualification and validation.
• Ensure GMP, safety, and regulatory compliance; have PM schedules, spare parts, and SOPs live in the CMMS at equipment start-up.
• Verify vendors meet compliance standards and are on the approved vendor list.
• Support capital planning, equipment upgrades, replacements, and obsolescence initiatives.

Collaboration and improvement

• Coordinate with Engineering, Operations, Quality, Validation, EHS, and Maintenance; support training, knowledge transfer, and documentation.
• Identify safety, reliability, efficiency, and cost improvements; support Lean, TPM, automation, and digital manufacturing initiatives.
• Promote engineering best practices and effective project turnover to Operations and Maintenance.

Candidate qualifications

• Strong technical knowledge of manufacturing and packaging equipment and utilities in a GMP-regulated environment.
• Proven experience managing capital projects, equipment installations, and contractors.
• Understanding of GMP, change control, deviations, CAPA, and IQ/OQ/PQ.
• Experience supporting pharmaceutical manufacturing or packaging operations.
• Engineering degree or similar degree.
• Strong collaboration, organization, communication, and problem-solving skills; able to lead projects and coordinate with site stakeholders.

Additional qualifications

• PMP, PgMP, Lean Six Sigma Black Belt, or CMRP credentials are listed as candidate credentials.
• Pharmaceutical production/support and technical-transfer experience is desirable but not essential if production skills are demonstrated.
• Knowledge of pharmaceutical processes, process development and validation, automation, equipment installation, HVAC, utilities, and facility systems is noted.

Performance measures