Job Summary

This position is responsible for providing engineering support and owns multiple systems, processes, or areas.   This position will primarily provide technical support of clean utilities and HVAC operations supporting a biologics production facility. 
This work includes working independently and with Manufacturing Operations, Quality, Outside Contractors, site IT and Manufacturing Science groups to generate technical solutions to a wide range of difficult problems.  Develops and maintains technical documents, drawings, and reports.  
Reviews engineering documents.  Monitors systems and develops strategies to improve performance and prevent problems. The position may include night and weekend work as well as on-call coverage.

Job Responsibilities

• Technical aspects include Architectural features, Structural/Civil, Biotech process and laboratory equipment and systems, HVAC, Plant and Clean Utility Systems, Electrical Power and Lighting, Automation.
• Project Management aspects include scope definition, scope adherence, stakeholder concurrence, budgeting, scheduling, risk management, procurement, and installation support, including coordinating the activities of contract engineers and trade contractors during system modifications/additions.
• Manages system performance, troubleshooting, deviation resolution, investigations, and readiness.
• Manages BMS (Building Management System) for follow-up and KPI on HVAC, Facilities, and energies consumption
• Develops and executes short-term and long-term plans to implement corrective actions, system reliability improvements, and risk mitigation.  This involves Change Control, qualification, and CAPA systems to meet the cGMP requirements of these proposed changed
• Develops, supports, and manages system documents, plans, protocols, procedures, changes control records.
• Supports new product introduction, including review of process requirements and parameters against equipment and system capabilities.  Defining equipment requirements, assessing gaps, and ensuring equipment readiness.
• Supports for maintenance functions on public service installations, including during technical shutdowns of installations, ensures facilities comply with all local, state, federal, and company guidelines related to health and environmental safety functions
• Assists with design, commissioning, and qualification of new equipment or system capabilities.
• Maintains a state of inspection and audit readiness for assigned systems and support regulatory inspections and client audits.
• Oversees work of independent contractors, as appropriate, and ensures all project specifications/requirements/codes are met while work is being performed on-site.
• Must be available to work occasional nights, weekends, holidays and to provide 24 hour 7 days a week on-call support as required. 

Minimum Requirements

• B.S. in Engineering (Chemical/Mechanical/Electrical/Energy), or equivalent work experience.
• A minimum of 6 years of experience in the pharmaceutical industry in engineering.
• Additional experience in manufacturing or technical operations within the biotechnology industry is a plus.
• French and English required