Job Description Reporting to the Engineering Manager, this role provides technical and project leadership across Engineering, Operations, Maintenance, Quality, Manufacturing, SHE/EHS, and Validation. The Engineering Operations & Project Lead will manage assigned capital and expense projects, coordinate engineering priorities and resources, resolve operational issues, and ensure work is completed safely, efficiently, and in compliance with GMP and company requirements. This position provides leadership and coordination without direct ownership of the Engineering department.
Key Responsibilities Project & Engineering Execution - Lead capital and expense projects from concept through commissioning, startup, and handover.
- Develop project scopes, schedules, cost estimates, URS, budgets, and execution plans.
- Manage contractors, vendors, and internal resources while tracking project progress, risks, costs, and deliverables.
- Communicate project status, priorities, risks, and resource needs to stakeholders and site leadership.
- Manage CAPEX activities in accordance with company policies and standards.
- Collaborate with project managers, PMO, and senior engineers to improve project execution methods and maintain project profitability.
GMP, Quality & Validation - Support Change Controls, Deviations, CAPAs, and other project-related Quality Records.
- Ensure engineering activities comply with GMP, safety, quality, and regulatory requirements.
- Support equipment qualification and validation activities, including IQ/OQ/PQ.
- Ensure new equipment is operationally ready at startup, including PM schedules, spare parts, SOPs, and required CMMS documentation.
- Verify that vendors meet compliance requirements and are maintained on the approved vendor list.
Capital Planning & Asset Lifecycle - Support capital planning, project justification, and prioritization.
- Coordinate equipment installations, upgrades, replacements, and obsolescence initiatives.
- Ensure effective project turnover to Operations and Maintenance.
Operations & Cross-Functional Support - Coordinate day-to-day engineering priorities based on safety, compliance, production impact, reliability, and business needs.
- Provide engineering support to Manufacturing, Packaging, and other site functions.
- Partner closely with Operations, Quality, Validation, EHS/SHE, Maintenance, and other stakeholders.
- Participate in and co-host project, PMO, and site meetings as needed.
- Support training, knowledge transfer, and documentation for new equipment and systems.
Continuous Improvement & Reliability - Identify opportunities to improve safety, equipment reliability, efficiency, and cost.
- Support Lean, TPM, automation, and digital manufacturing initiatives.
- Promote engineering standards and best practices across the site.
- Help reduce repeat issues, project-related downtime, and operational disruptions.
Skills & Experience - Strong technical knowledge of pharmaceutical manufacturing and/or packaging equipment and utilities in a GMP-regulated environment.
- Demonstrated experience managing capital projects, equipment installations, contractors, and vendors.
- Strong understanding of GMP requirements, Change Control, Deviations, CAPAs, and equipment qualification/validation (IQ/OQ/PQ).
- Experience supporting pharmaceutical manufacturing or packaging operations.
- Knowledge of pharmaceutical manufacturing processes, process development, and validation.
- Exposure to automation, equipment installations, and validation activities.
- Working knowledge of HVAC, utilities, and facility systems.
- Strong project management, organizational, communication, problem-solving, and stakeholder-management skills.
- Ability to lead individual projects while coordinating multiple cross-functional priorities.
Preferred: Experience with technical transfer of pharmaceutical products and production.
Qualifications - Bachelor's degree in Engineering or a related technical discipline.
- Relevant professional certifications such as PMP, PgMP, Lean Six Sigma Black Belt, and/or CMRP are highy desirable.
Key Competencies Project Management • Problem Solving • Commercial & Business Acumen • Relationship Management • Stakeholder Engagement • Customer Service • Results Focus • Technical Knowledge
Key Performance Indicators Success will be measured through: - Projects delivered safely, on schedule, and within budget, with a target of 90% on-time execution.
- Contractor safety and compliance performance.
- Effective project turnover and documentation completion.
- Successful startup and performance of new equipment with 100% preventive maintenance readiness at handover.
- Reduction in project-related downtime, disruptions, and repeat equipment issues.
- Timely closure of Change Controls, Deviations, and CAPAs, with a target of 91%.
- Project-related audit findings and compliance performance.
- Continuous improvement initiatives and measurable cost savings or avoidance.
Success in This Role The successful candidate will consistently: - Deliver engineering projects safely, on schedule, and within budget.
- Effectively coordinate daily engineering priorities and resources.
- Proactively identify and resolve engineering and operational issues.
- Provide strong technical and project leadership across cross-functional teams.
- Maintain compliance with GMP, safety, quality, and company requirements.
- Improve equipment reliability, site performance, and operational efficiency.
- Keep the Engineering Manager and site leadership informed of project status, risks, and resource needs.
