Utilities & Facilities Engineer
hace 2 días
Raleigh
Job DescriptionJob Title: Utilities and Facilities EngineerJob Description This role provides technical leadership and hands-on support for clean utilities, plant utilities, and facilities systems in a regulated manufacturing environment. The Utilities and Facilities Engineer ensures reliable operation of critical systems such as cleanroom HVAC, water for injection, and other utilities while maintaining strict compliance with GMP, FDA, and ISO requirements. The position combines field-based troubleshooting, engineering ownership, project leadership, and quality documentation to support safe, efficient, and compliant manufacturing operations. Responsibilities • Provide technical guidance and field support to maintenance technicians and utility operators during maintenance, troubleshooting, and operational activities., • Support day-to-day operation and maintenance of clean utilities and plant utilities, ensuring reliable and compliant performance., • Serve as engineering support during system deviations, alarms, and operational issues, helping to diagnose root causes and implement effective solutions., • Develop, review, and approve maintenance strategies for critical utilities and facilities systems, including preventive maintenance optimization and reliability improvements., • Collaborate with maintenance teams to define preventive and predictive maintenance requirements aligned with system criticality and risk., • Support spare-parts strategies and lifecycle planning for utilities assets to minimize downtime and ensure continuity of operations., • Act as engineering owner for cleanroom HVAC systems, including air handling units, pressure cascades, temperature, humidity, and airflow control., • Oversee and ensure HEPA filter certification, airflow velocity testing, and overall cleanroom environmental compliance., • Support investigations and corrective actions related to HVAC and environmental excursions, ensuring timely resolution and documentation., • Lead and support utilities and facilities projects, including system upgrades, remediation efforts, and capacity expansions., • Coordinate with contractors, vendors, and internal stakeholders to ensure projects are executed safely, on schedule, and in compliance with GMP requirements., • Participate in design reviews, risk assessments, and commissioning activities for utilities and facilities systems., • Manage and support deviations, change controls, and CAPAs related to utilities and facilities systems, ensuring accurate and timely documentation., • Ensure documentation and system operation adhere to ALCOA+ data integrity principles., • Support regulatory inspections, external audits, and internal quality reviews related to utilities, facilities, and environmental controls., • Develop and deliver training programs for utility operators and maintenance technicians on systems, procedures, and compliance requirements., • Serve as engineering and facilities owner for the site pest control program, ensuring program effectiveness and regulatory compliance., • Coordinate with pest control vendors to maintain accurate documentation and ensure GMP-compliant execution of the program., • Support site emergency response related to utilities failures or facility issues, including troubleshooting and coordination of corrective actions., • Support technical investigations and updates to maintenance documentation, procedures, and technical records., • Collaborate closely with Quality, Validation, Production, and EHS teams to support compliance initiatives and continuous improvement., • Contribute to a culture of safety, quality, and continuous improvement within the utilities and facilities function.Essential Skills, • Minimum of 5–10 years of experience in utilities and facilities engineering within a pharmaceutical, biotech, or regulated manufacturing environment., • Demonstrated experience with clean utilities, including systems such as WFI and related critical utilities., • Proven experience with HVAC systems, including cleanroom environmental controls and air handling units., • Demonstrated experience in leading CAPA, change control, and compliance documentation processes., • Strong understanding of GMP regulations and their application in a manufacturing environment., • Strong understanding of FDA and ISO regulations relevant to pharmaceutical or regulated manufacturing., • Ability to interpret technical drawings, P&IDs, specifications, and validation documentation., • Strong understanding of ALCOA and ALCOA+ data integrity principles and their practical application., • Proficient in Microsoft Office applications for documentation, analysis, and reporting., • Experience working within Quality Management Systems (QMS)., • Excellent analytical and problem-solving skills with the ability to make sound decisions under pressure., • Strong attention to detail and commitment to data integrity and documentation accuracy., • Effective written and verbal communication skills for cross-functional collaboration and documentation., • Ability to manage multiple priorities and deadlines under minimal supervision., • Capability to interpret and apply complex regulations and quality standards to utilities and facilities operations., • Ability to interpret engineering drawings, maintenance procedures, and regulatory requirements., • Strong leadership and interpersonal communication skills to influence and guide cross-functional teams., • Demonstrated reliability and accountability in supporting critical utilities and facilities operations.Additional Skills & Qualifications, • Bachelor's Degree in Engineering (Mechanical, Electrical, Industrial, or related field) required., • Master's Degree in Engineering or a related discipline preferred., • Strong organizational, planning, and decision-making skills., • Strong critical thinking abilities and sound judgment in complex technical situations., • Experience with reliability-focused maintenance strategies and spare-part planning., • Familiarity with HIPAA and data privacy expectations in a regulated environment., • Demonstrated ability to lead cross-functional initiatives and projects., • Capacity to work effectively in a fast-paced, highly regulated manufacturing setting., • Motivation for continued personal development and willingness to learn new technologies and regulations., • Interest in contributing to innovative solutions that improve patient outcomes and healthcare quality.Work Environment This is an on-site role in a manufacturing plant environment. The position involves a combination of normal office conditions and significant time spent on the production floor and within facilities and utilities areas. The role requires frequent access to cleanrooms, mechanical spaces, utility rooms, and other typical pharmaceutical production environments, including areas with controlled temperature, humidity, and pressure. Standard business hours apply, with flexibility required to support off-shift or weekend work for manufacturing operations, projects, audits, or emergency responses. The role may involve occasional participation in regulatory inspections and emergency situations outside of regular working hours. Physical activities include sitting, standing, and walking for extended periods in both office and manufacturing settings, as well as climbing ladders, accessing rooftops, and entering mechanical rooms as needed. The position requires frequent use of personal protective equipment (PPE), including cleanroom garments, safety gear, and respiratory protection when required, in accordance with site safety and GMP standards. The work environment promotes collaboration, continuous improvement, and a strong focus on safety, quality, and innovative solutions that support better patient outcomes and ongoing professional development. Job Type & Location This is a Contract position based out of Raleigh, NC. Pay and Benefits The pay range for this position is $45.00 - $55.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Raleigh,NC. Application Deadline This position is anticipated to close on Jul 31, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.