The Senior Project Engineer is responsible for leading the planning, coordination, and execution of a cleanroom upgrade project. This includes managing cross-functional activities (production, work statement, transportation, installations, testing and commissioning of new infrastructure, facilities, equipment, technical scopes, contractor performance, and ensuring project delivery within defined timelines, budget, safety, and regulatory expectations
This is a temporary assignment of up to 12 months focused on a high-priority strategic upgrade for the site's cleanroom infrastructure and utilities.
**Responsibilities**:
Oversee all phases of the cleanroom upgrade project, from design to handover, ensuring alignment with operational needs and compliance standards.
Manage the interface between contractors and internal stakeholders (e.g., maintenance, Quality, microbiology, validation, EHS, production, logistics and engineering) Supervise and coordinate activities related to HVAC, chilled water, compressed air, electrical systems, ventilation, structural modifications, fire protection systems, finishes, Building Management System integration (BMS) and cleanroom certification.
Develop and track project schedules, deliverables, and risk mitigation plans.
Ensure project execution meets safety, quality (ISO 13485, GMP, FDA), ISO 14001, safety and energy management requirements.
Support validation and qualification protocols for cleanroom certification.
Track project KPIs and prepare regular status reports for site leadership and general stakeholders.
Maintain records related to technical decisions, changes, and approvals.
Act as the central point of contact between internal users and external contractors.
Deliver accurate documentation related to maintenance activities, calibration,



compliance logs, and technical procedures for the equipment’s added.
Mentor facilities staff and participate in cross-site technical forums and knowledge sharing initiatives.
Coordinate clean room validation deeply involving the cross-functional team to deliver a successful certification.
Meet our quality, safety and environmental policy.
Approve technical documentation, technologies and validation within project scope
Stop project operations if facility conditions risk quality or safety.
Suggest minor purchases approval within the project budget.
Lead emergency response actions for facility incidents.
Authorize temporary changes or interventions in the facilities systems in case of emergencies.
Report and escalate facility-related risks to management.
Recommend strategies, upgrades to enhance the scope.
Initiate RCA/CAPA processes and lead resolution of deviations if required. Lead vendor selection processes for equipment and services under assigned projects.
**Requirements**:
Bachelor’s degree in Mechanical, Electrical, Mechatronics, or Industrial Engineering
3 to 5 years of experience in facility or infrastructure projects in a regulated manufacturing environment.
Proven experience managing multidisciplinary engineering projects (preferably cleanroom upgrades or controlled environments).
Written and spoken English required.




Strong knowledge of HVAC, utilities, cleanroom design, validation, and regulatory standards (ISO 14644).
CCR (Change Control Record) management.
Knowledge of requirements of FDA QSR's GMP's and ISO 13485 or similar regulations.
Solid understanding in the ISO 14001:2015, interpretation of ISO 45001 and 50001.
Excellent organizational, communication, and coordination skills.
Experience with project planning tools (e.g., MS Project, Excel and AUTOCAD). Knowledge of RCA and risk-based decision-making in technical projects.
Experience on budget administration.
Experience on building installations and equipment’s.
PMP certification preferable.
Knowledge in construction processes.
Induction to ISO 14001:2015. Induction on Environmental Legal Requirements, Training on Applicable Environmental Management System Documents, Disaster Care and Response, Applicable Operational Controls, Determination of Applicable Significant Environmental Aspects, and Impacts, EHS Policy and Environmental Objectives.
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📌 Project Senior Engineer, Facilities - Temporary Contract, 1 Year (Del Norte)
🏢 Convatec
📍 Del Norte