Onsite Engineering Lead - Pharma CQV & GMP (KY)

Pinnaql; Hebron Estates (KY); On-site; USD 120,000 - 160,000; Full time

Job summary

Validation & Engineering Group in Kentucky is seeking a hands-on Engineering Site Lead to provide onsite engineering leadership at an FDA‑regulated manufacturing facility. You will coordinate cross-functional teams across CQV, Automation, Process, Facilities, Maintenance, Quality and Operations to drive project execution, commissioning, qualification and validation activities.

This role requires 8+ years in FDA-regulated environments, strong GMP/CQV knowledge, and excellent communication to keep

Qualifications

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

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 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.

Skills

Onsite leadership

GMP knowledge

CQV experience

Stakeholder management

Industrial automation

Job description

Validation & Engineering Group in Kentucky is seeking a hands-on Engineering Site Lead to provide onsite engineering leadership at an FDA‑regulated manufacturing facility. You will coordinate cross-functional teams across CQV, Automation, Process, Facilities, Maintenance, Quality and Operations to drive project execution, commissioning, qualification and validation activities.

This role requires 8+ years in FDA-regulated environments, strong GMP/CQV knowledge, and excellent communication to keep