Engineering Site Lead

Pinnaql, Inc.; Hebron Estates (KY); On-site; USD 120,000 - 180,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks an Engineering Site Lead to provide onsite engineering leadership at an FDA-regulated manufacturing facility in Kentucky.

The role coordinates cross-functional teams and drives engineering, CQV, and equipment activities with a focus on GMP compliance and site safety.

Qualifications

• 8+ years of engineering experience within FDA-regulated environments.
• Experience leading onsite engineering activities and cross-functional teams.
• Strong knowledge of GMP and CQV requirements.
• Hands-on experience with manufacturing or laboratory equipment and systems.
• Ability to work onsite in Hebron, Kentucky.

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

Job description

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, is a leading services provider delivering solutions to the Pharmaceutical, Biotechnology, Medical Device, Chemical, and Food industries across Engineering, Project Management, Validation, Compliance, Laboratory, and Computer Systems.

We are seeking a talented, dedicated professional committed to the highest ethical standards for the following position:

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)

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'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.