Project Engineer, Quality Engineering

The Project Engineer is responsible for the planning, execution, and delivery of capital and technical projects that support manufacturing, packaging, utilities, and facility operations. This role ensures projects are delivered safely, on time, within budget, and in compliance with GMP, safety, and regulatory requirements. The Project Engineer partners cross‑functionally with Operations, Quality, Validation, EHS, Maintenance, and external contractors to support business growth, lifecycle management, and continuous improvement initiatives in a pharmaceutical manufacturing environment.

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

• Support Change Controls, Deviations, CAPAs, and Quality Records related to projects.
• Ensure project activities comply with GMP, safety, and regulatory standards.
• Support equipment qualification and validation activities (IQ/OQ/PQ).
• Ensure that on the day the new equipment starts running, the PM schedules, spare parts, and SOPs are already live in the CMMS (Maintenance System).
• Validate that all vendors meet compliance standards and are active in the approved vendor list.

• Support capital planning, justification, and prioritization activities.
• Coordinate equipment upgrades, replacements, and obsolescence initiatives.
• Ensure effective turnover of projects to Operations and Maintenance.

• Act as a liaison between Engineering, Operations, Quality, Validation, EHS, and Maintenance.
• Support training, knowledge transfer, and documentation related to new systems and equipment.

• Identify opportunities to improve safety, reliability, efficiency, and cost.
• Support Lean, TPM, automation, and digital manufacturing initiatives.
• Promote standardization and engineering best practices across the site.

• Projects delivered on time and within budget (90%)
• Contractor safety performance and compliance
• Effective project turnover and documentation completion

• Reduction in project‑related downtime and disruptions
• Successful startup and performance of new equipment

• On‑time closure of Change Controls, Deviations, and CAPAs (91%)
• Audit findings related to project execution (count/severity)

• Preventive maintenance readiness at project handover (100%)
• Reduction in repeat issues related to new installations

• Number of improvement initiatives supported
• Cost savings or avoidance achieved ($)

• Strong technical knowledge of manufacturing, packaging equipment, and utilities in a GMP‑regulated environment.
• Proven experience managing capital projects, equipment installations, and contractors.
• Solid understanding of GMP compliance, including change control, deviations, CAPAs, and equipment qualification (IQ/OQ/PQ).
• Experience supporting pharmaceutical manufacturing or packaging operations.
• Engineering degree or similar degree
• PMP
  - Project Management Professional
• PgMP
  - Program Management Professional
• Lean Six Sigma Black Belt
• CMRP
  - Certified Maintenance & Reliability Professional

• Effective cross‑functional collaboration with Operations, QA, Validation, EHS, and Maintenance.
• Strong organizational, communication, and problem‑solving skills.
• Ability to lead individual projects while co‑ordinating with site…