Validation & Engineering Group, Inc. a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethical standards for the following position:
- Engineering Site Lead
We’re looking for a hands-on Engineering Site Lead to support a fast-paced project at an FDA-regulated manufacturing facility in Kentucky. This is an immediate opportunity for a high-visibility onsite engagement with strong potential to transition into a long-term role.
Description:
- Lead all onsite engineering activities and serve as the primary point of contact
- Coordinate cross functional teams (CQV, automation, process, facilities)
- Drive daily execution, track milestones, and keep the project on schedule
- Identify and resolve issues quickly to maintain progress
- Support commissioning, qualification, and validation (CQV) activities
- Ensure compliance with GMP and safety standards
- Communicate updates clearly with stakeholders
Qualifications:
- 8+ years of engineering experience in pharma, biotech, or medical device environments
- Proven experience in site leadership or project execution roles
- Strong knowledge of CQV and GMP environments
- Ability to work independently and lead on-site teams effectively
- Strong communication and problem-solving skills
Preferred
- Experience with manufacturing or lab equipment
- Familiarity with automation systems
- Experience in fast-paced or short-term project environments
Why This Role?
- Immediate impact in a high-visibility project
- Opportunity to take ownership on-site
- Potential to convert to a long term role based on performance and project needs
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.
Skills Required
- 8+ years of engineering experience in pharma, biotech, or medical device environments
- Proven experience in site leadership or project execution roles
- Strong knowledge of CQV (commissioning, qualification, validation)
- Strong knowledge of GMP environments
- Ability to work independently and lead on-site teams effectively
- Strong communication and problem-solving skills
- Experience with manufacturing or laboratory equipment
- Familiarity with automation systems
- Experience in fast-paced or short-term project environments
What We Do
Pinnaql, Inc. is a professional services consulting firm providing quality, regulatory, and operational excellence solutions to biopharmaceutical, medical device, and CDMO companies worldwide. The company specializes in laboratory validation, engineering, and compliance, helping regulated life sciences organizations navigate manufacturing challenges, reduce execution risks, and accelerate the transition from lab innovation to commercial market readiness.
