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Lead the design, optimization, and reliability of critical utility systems—focused on HVAC and environmental controls—that power the delivery of high-quality, life-changing therapies. You will own systems such as isolator air handlers and HEPA filtration units, ensuring compliance, performance, and continuous improvement.
Job Responsibility:
Serve as the system owner for assigned utilities, ensuring compliance with cGMP and regulatory standards
Monitor system performance daily and ensure operational reliability and environmental requirements are met
Own the lifecycle management of assigned systems, supporting preventive and predictive maintenance strategies
Ensure maintenance job plans and documentation are follows site standards and regulatory expectations
Evaluate systems and assess impact during outages or deviations, providing timely technical support and documentation
Participate in project meetings, offering technical expertise for design reviews and system modifications
Author and maintain user requirement specifications and system documentation
Identify and implement design or operational improvements to enhance efficiency and reliability
Incorporate industry best practices and regulatory updates into system design and operations
Lead root cause analysis for major deviations or failures, driving resolution with multi-functional teams
Analyze performance data to identify trends, anomalies, and opportunities for improvement
Translate technical insights into clear, actionable updates for non-technical collaborators
Collaborate with internal customers to understand needs and align engineering solutions accordingly
Share knowledge and best practices across teams and sites to promote consistency, innovation, and continuous improvement
Requirements:
Doctorate degree in Engineering
Master’s degree in Engineering and 2 years of Engineering and/or Mfg Support experience
Bachelor’s degree in Engineering and 4 years of Engineering and/or Mfg Support experience
Working knowledge of pharmaceutical and biotechnology processes
Specialized expertise in industrial utilities, specifically in HVAC systems
Experience with utilities monitoring systems, including Building Management System (BMS), Process Control System (PCS), and PI data historian
Familiarity with Quality Management Systems (QMS), including validation, deviations, and CAPA management
Strong skills in problem solving, negotiation, persuasion, collaboration, project cost development, conflict resolution, leadership, team building, and schedule/resource planning
Effective verbal and written communication skills
proficiency in both Spanish and English
Flexibility to work extended shifts and/or weekends as required by business needs
Nice to have:
Working knowledge of pharmaceutical and biotechnology processes
Specialized expertise in industrial utilities, specifically in HVAC systems
Experience with utilities monitoring systems, including Building Management System (BMS), Process Control System (PCS), and PI data historian
Familiarity with Quality Management Systems (QMS), including validation, deviations, and CAPA management
Strong skills in problem solving, negotiation, persuasion, collaboration, project cost development, conflict resolution, leadership, team building, and schedule/resource planning
Effective verbal and written communication skills
proficiency in both Spanish and English
Flexibility to work extended shifts and/or weekends as required by business needs
What we offer:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and an annual site shutdown