Engineering Site Lead
Listed on 2026-08-21
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Engineering
Validation Engineer, Quality Engineering, Process Engineer, Manufacturing Engineer
Engineering Site Lead
We are seeking a hands-on Engineering Site Lead to provide onsite engineering leadership at an FDA-regulated manufacturing facility in Kentucky. This highly visible role will serve as the primary engineering point of contact, coordinating cross-functional teams and driving the successful execution of engineering, equipment, automation, and CQV activities.
Responsibilities- Lead and coordinate day-to-day onsite engineering activities
- Serve as the primary engineering point of contact for site stakeholders
- Coordinate cross-functional teams, including CQV, Automation, Process, Facilities, Maintenance, Quality, and Operations
- Drive project and engineering execution, priorities, schedules, milestones, and deliverables
- Proactively identify and resolve technical, schedule, and operational issues
- Support commissioning, qualification, and validation (CQV) activities for manufacturing and laboratory equipment and systems
- Support equipment installation, startup, upgrades, troubleshooting, and continuous improvement initiatives
- Ensure engineering activities comply with GMP, safety, quality, and site requirements
- Provide clear, timely communication on project status, risks, priorities, and issues to key stakeholders
- 8+ years of engineering experience within pharmaceutical, biotechnology, medical device, or other FDA-regulated manufacturing environments
- Demonstrated experience leading onsite engineering activities, projects, or cross-functional technical teams
- Strong knowledge of GMP and CQV requirements
- Hands-on experience with manufacturing and/or laboratory equipment and systems
- Experience supporting equipment installation, startup, qualification, troubleshooting, or optimization
- Familiarity with industrial automation and controls systems
- Strong project execution, problem-solving, and organizational skills
- Ability to independently manage priorities and drive issues through resolution
- Excellent communication and stakeholder management skills
- Ability to work onsite in Hebron, Kentucky (greater Cincinnati area)
At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job—it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you. Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
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