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
Qualifications - 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)
