Manager Quality Engineering Validation

About McGuff Pharmaceuticals

For more than two decades, McGuff Pharmaceuticals has been a trusted leader in sterile pharmaceutical manufacturing. We are an FDA-registered drug manufacturer and FDA 503B outsourcing facility committed to quality, patient safety, and operational excellence.

As a family-owned and veteran-owned organization, we offer something increasingly rare in today's marketplace: stability, accessibility of leadership, and the opportunity to make a meaningful impact.

We are seeking an exceptional leader to manage our Quality Engineering – Validation (QEV) team and help shape the future of quality, validation, and manufacturing excellence at McGuff.

The Opportunity

This is more than a validation management role.

McGuff seeks a leader who can help modernize and advance our validation and quality engineering programs through the use of science, risk-based decision making, advanced analytics, digital systems, automation, and emerging technologies. The successful candidate will not only maintain compliance but help shape the future of pharmaceutical quality and manufacturing excellence within our organization.

The successful candidate will lead a team of validation engineers while working closely with Manufacturing, Engineering, Quality Assurance, and Executive Management.

What You'll Do

• Lead, mentor, and develop a team of validation engineers.

• Ensure facilities, equipment, utilities, computerized systems, and manufacturing processes remain in a validated state.

• Oversee qualification and validation activities including IQ/OQ/PQ, process validation, cleaning validation, and computerized system validation.

• Lead complex investigations, root cause analyses, and CAPA activities.

• Utilize data, statistics, and risk-based decision making to improve process performance and product quality.

• Maintain and continuously improve the Validation Master Plan (VMP).

• Partner with Engineering, Manufacturing, and QA to drive operational excellence and inspection readiness.

• Support implementation and improvement of digital quality and manufacturing systems.

• Represent McGuff during FDA inspections, customer audits, and quality reviews.

Who You Are

• A leader who enjoys developing people and building high-performing teams.

• A coach and mentor who believes in training and continuous learning.

• A hands-on problem solver who enjoys tackling complex technical challenges.

• A strategic thinker capable of balancing long-term objectives with practical execution.

• A professional who thrives in a collaborative environment and communicates effectively across all levels of the organization.

• Someone excited about the future of pharmaceutical manufacturing, automation, analytics, and quality systems.

What You Bring

• Bachelor's or Master's degree in Engineering, Life Sciences, or a related technical discipline.

• Approximately 8+ years of experience in pharmaceutical manufacturing, validation, quality engineering, process engineering, manufacturing science, or related technical roles.

• Leadership experience with responsibility for projects, teams, or direct reports.

• Experience with validation lifecycle activities including equipment qualification, process validation, cleaning validation, or computerized system validation.

• Strong understanding of FDA cGMP requirements and validation principles.

• Experience with root cause analysis, investigations, and CAPA systems.

• Strong technical writing, communication, and presentation skills.

• Experience in sterile pharmaceutical manufacturing is highly desirable.

Why McGuff

• Stable and growing company with a long history of success.

• Family-owned and veteran-owned organization.

• Direct access to senior leadership and decision makers.

• Opportunity to influence the future direction of Quality Engineering and Validation.

• Collaborative culture that values initiative, innovation, and continuous improvement.

• Competitive compensation and comprehensive benefits.

• Significant opportunity for professional growth and advancement.

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