Engineer-Utilities & HVAC | GMP Pharmaceutica

Job Description

Job Description

Engineer II – Utilities & HVAC | GMP Pharmaceutical Manufacturing | New Facility Start-Up
Location: Petersburg, VA
Industry: Pharmaceutical Manufacturing
Employment Type: Full-Time
Make an Impact on a New Pharmaceutical Manufacturing Facility
We are seeking an experienced Engineer II – Utilities & HVAC to join our team in Petersburg, VA. This is an exciting opportunity to play a key technical role in the final phase of construction, commissioning, and start-up of a new pharmaceutical manufacturing facility , and then transition into supporting the site's ongoing operations.
In this role, you will serve as the Site Subject Matter Expert (SME) for critical GMP utility and HVAC systems, including Water for Injection (WFI), Clean Steam, Process Compressed Air, Nitrogen, GMP HVAC, and related ancillary systems .
You will be responsible for ensuring these critical systems are reliable, compliant, safe, efficient, and fit for use in a pharmaceutical manufacturing environment. You will also have the opportunity to influence capital projects, lead continuous improvement initiatives, troubleshoot complex system issues, and partner closely with Engineering, Maintenance, Operations, Quality, HSE, and other cross-functional teams.
What You'll Do

• Serve as the technical SME for GMP Utilities, HVAC, and associated ancillary systems supporting pharmaceutical manufacturing.
• Provide technical expertise related to system applications, process parameters, flow diagrams, equipment performance, and industry best practices.
• Support the final stages of construction, commissioning, qualification, and start-up of the new manufacturing facility.
• Lead or participate in projects and system changes, including design activities, verification and qualification activities such as IQ/OQ/PQ , and capital project execution.
• Develop and review technical documentation, including User Requirements (URs), specifications, test cases, procedures, and qualification documentation .
• Ensure systems remain in a validated, controlled, compliant, and fit-for-use state.
• Monitor utility and HVAC performance and establish and maintain KPIs to ensure reliability, compliance, and effective operation.
• Develop operating and maintenance procedures to ensure systems remain within established control parameters.
• Implement maintenance, reliability, and continuous improvement strategies that improve system performance and efficiency.
• Lead troubleshooting and equipment failure investigations, including Root Cause Analysis (RCA) , and guide Operations and Maintenance teams in resolving complex technical issues.
• Support risk assessments using tools such as FMEA and participate in Process Hazard Reviews and safety teams as needed.
• Provide technical consultation and support to Maintenance, Operations, Quality, Engineering, and other site stakeholders.
• Ensure utility-related issues are appropriately documented, tracked, communicated, and resolved within required timelines.
• Support internal and external inspections, audits, investigations, and regulatory activities, including Quality and HSE inspections.
• Develop, maintain, and deliver training related to utility and HVAC systems.
• Utilize statistical analysis and process capability tools to support investigations and process control.
• Maintain proficiency with Document Management Systems (DMS), CAPA systems , and other applicable site systems.
• Identify opportunities for continuous improvement and local capital investment to enhance reliability, efficiency, compliance, and overall site performance.

What We're Looking For
Required:

• Bachelor's degree in Engineering, Science, or a related technical discipline .
• 6+ years of experience working with GMP Utilities in a pharmaceutical, biotech, or other regulated manufacturing environment.
• Strong technical knowledge of GMP utility systems and HVAC within a pharmaceutical manufacturing environment.
• Experience with equipment/system qualification and validation activities, including IQ/OQ/PQ .
• Experience with troubleshooting, investigations, root cause analysis, and corrective/preventive actions.
• Ability to interpret P&IDs, flow diagrams, system specifications, and process parameters .
• Strong understanding of GMP, regulatory expectations, and controlled manufacturing environments.
• Demonstrated ability to manage multiple priorities and deliver results in a fast-paced environment.
• Strong written and verbal communication skills.
• Ability to collaborate effectively across Engineering, Operations, Maintenance, Quality, HSE, and other cross-functional teams.
• Ability to work independently while also effectively influencing and partnering within a matrixed organization.

Preferred:

• Experience supporting a new facility start-up, commissioning, or technology transfer .
• Advanced degree or relevant professional certification.
• Experience with continuous improvement, reliability engineering, or capital project execution.
• Experience with statistical analysis and process capability tools.

What Makes This Opportunity Unique
This is more than a day-to-day utilities engineering position. You will have the opportunity to help bring a brand-new pharmaceutical manufacturing facility online , establish reliable and compliant utility systems, and then become a key technical resource for the site's ongoing operations.
The person in this role will have visibility across the organization and will work closely with a broad range of technical and operational teams. If you enjoy solving complex problems, working on critical systems, and having a direct impact on the reliability and success of a manufacturing site, this could be an excellent opportunity.
The Ideal Candidate
We are looking for someone who can think both strategically and tactically —someone who can step back and understand the bigger picture while also being comfortable diving into technical details when a system or process needs attention.
The successful candidate will be:

• Technically strong and solutions-oriented
• Detail-oriented without losing sight of the big picture
• Comfortable taking ownership and making decisions
• A strong problem solver and investigator
• Collaborative and able to influence across functions
• Self-motivated and comfortable working independently
• Adaptable in a fast-paced, start-up environment
• Positive, professional, and committed to achieving team and site goals

Physical Requirements & Work Environment
This position requires regular communication and use of hands and fingers to operate equipment, tools, and controls. The role may occasionally require standing, walking, sitting, reaching, and lifting or moving up to 25 pounds .
Because this position supports a pharmaceutical manufacturing environment, the successful candidate must be able to successfully complete aseptic gowning requirements, procedures, and certification .
The work environment is generally low to moderate in noise. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.

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