Senior Facilities/Utilities Engineer

Trinity Consultants - Advent Engineering; California; Presencial; USD 150 000 - 210 000; Tempo integral

Resumo da oferta

Trinity Consultants - Advent Engineering in California seeks a Principal Facilities and Utilities Engineer to design and review critical facility systems in a regulated Life Sciences setting. The role focuses on HVAC, water, steam, compressed air, and electrical infrastructure, while ensuring reliability and compliance.

You will lead preventive maintenance, SOP development, and CAPA initiatives, collaborate across departments, and drive energy efficiency and capital upgrade projects.

Qualificações

• Bachelor's degree in Life Sciences or related field is required.
• 10+ years of engineering experience in Life Sciences industry and consulting is preferred.
• Experience delivering large-scale engineering projects in a regulated setting.

Responsabilidades

• Oversee preventive and predictive maintenance programs to minimize downtime and ensure regulatory compliance (cGMP, FDA, ICH).
• Develop, update and train SOPs, work instructions, and maintenance logs for facility and utility systems.
• Manage IQ/OQ/PQ start-up, commissioning and validation of facility equipment.
• Lead or support RCA and CAPA for equipment failures or deviations.
• Collaborate with Engineering, Operations, HSE and QA to meet standards and production needs.
• Monitor energy efficiency and sustainability initiatives to reduce costs.
• Oversee contractors and vendors performing maintenance, repairs, or upgrades.
• Support capital projects from design through validation and hand-over to Facilities Department.
• Maintain audit readiness and proper change control documentation.
• Stay updated with industry best practices and regulatory changes.

Conhecimentos

SAP

CMMS

SCADA/BMS

HAZOPs

CAPA

AutoCAD

Formação académica

Bachelor’s degree in Life Sciences related field

Ferramentas

PipeFlo

Descrição da oferta de emprego

The Principal Facilities and Utilities Engineer is responsible for designing and reviewing critical facility systems - including HVAC, water, steam, compressed air and chilled water systems and electrical infrastructure - in compliance with cGMP and regulatory standards. This role plays a pivotal role in ensuring reliable facilities operations, creating and updating preventive maintenance programs, equipment troubleshooting, and implementing solutions to minimize downtime and optimize performance. The Principal Facilities and Utilities Engineer collaborates with cross-functional teams to support facility upgrades, energy efficiency initiatives, and capital improvement projects. Strong technical expertise, problem-solving skills, and a focus on continuous improvement are essential for success in this role.

ESSENTIAL DUTIESAND RESPONSIBILITIES

• Knowledge and experience in:
• Oversee preventive and predictive maintenance programs (e.g SAP/CMMS) to minimize downtime and ensure compliance with cGMP, FDA, ICH, and other regulatory requirements.
• Implement innovative solutions and continuous improvement initiatives to optimize operational performance.
• Develop, update and train mechanics on Standard Operating Procedures (SOPs), work instructions, and maintenance logs for facility and utility systems.
• Manage start-up, commissioning, qualification, and validation (IQ/OQ/PQ) of facility equipment to ensure compliance with regulatory standards.
• Lead or support root cause analysis (RCA) and implement corrective/preventive actions (CAPA) for equipment failures or deviations.
• Collaborate with Engineering, Operations, Health, Safety and Environment (HSE), and Quality Assurance teams to ensure facility systems meet industry standards, regulatory compliance and production needs.
• Monitor and optimize energy efficiency, sustainability initiatives, and utility consumption to reduce operational costs.
• Oversee contractors and vendors performing maintenance, repairs, or upgrades on facility systems.
• Support capital projects, facility expansions, and equipment upgrades from design through validation and hand-over to Facilities Department.
• Ensure reliability and adherence with cGMP compliance by maintaining proper documentation, change control management, and audit readiness.
• Conduct risk assessments and implement mitigation strategies for critical utility systems.
• Maintain emergency response plans for critical utilities (e.g., backup power, water systems) to ensure business continuity.
• Participate in internal and external audits, providing necessary documentation and corrective actions as required.
• Working knowledge in SCADA/BMS.
• Familiarity in instrumentation, calibration and components for utility equipment and facilities.
• Familiar with pharmaceutical facility design such as air exchanges, differential pressures and flow directions.
• Familiarity with ASME BPE standard and ASME B31.3 and B&PV code.
• Participate in design reviews, HAZOPs, and constructability reviews to ensure quality and safety.
• Manage and resolve design changes and field issues during construction.
• Work closely with clients and stakeholders to gather requirements and present technical solutions.
• Oversees strategic planning, team coordination, and long-term reliability of systems
• Familiar with utilizing and reviewing hydraulic simulation model software e.g., PipeFlo.
• Stay updated with industry best practices, regulatory changes, and new technologies in pharmaceutical facilities management.
• Leads larger scale projects - facility expansions, new utilities installations, etc.

SUPERVISORY RESPONSIBILITIES

Directly supervise several technical team members on the project, including training, planning, assigning, and directing work.

QUALIFICATIONS

Proven experience in design, maintenance and troubleshooting of facility systems in a regulated environment, excellent problem-solving skills, with a commitment to continuous process improvement are required. Experience in consulting and engaging clients in projects in a dynamic schedule environment while multi-tasking other responsibilities.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The listed requirements are representative of the knowledge, skills, and abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and EXPERIENCE

• Bachelor’s degree (B.S.) in Life Sciences related field from a four-year college or university or foreign equivalent.
• Experience in consulting in Life Sciences industry and participating in delivering successful large-scale engineering projects.
• The candidate ideally would have a minimum of 10+ years of experience in engineering within the Life Sciences sector.
• Must be computer literate, including word processing, spreadsheet skills, and knowledge of Microsoft Office software package and drafting skills in AutoCAD.