Engineering Site Lead

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 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 direct hire permanent position Engineering Site LeadWe 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 andor 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 youre empowered to do your best work bold ideas thrive and real progress happens This isnt just a jobits 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 LI LN1 LI ONSITE