Manager, Quality Engineering - Validation

Manager, Quality Engineering

• Validation at McGuff Companies Manager, Quality Engineering
• Validation at McGuff Companies in Fountain Valley, California Posted in about 24 hours ago.

Type:

full-time

Job Description:

About McGuff Pharmaceuticals, Inc. For more than two decades, McGuff Pharmaceuticals, Inc. (McGuff) has been a trusted leader in sterile pharmaceutical manufacturing. We are an FDA-registered commercial drug manufacturer and

FDA 503B

outsourcing facility known for our integrity, precision, and innovation. As a family

• and veteran-owned organization, McGuff Medical is committed to excellence in every aspect of sterile production
• from concept to patient care. We are seeking a strong, motivational leader to manage our Quality Engineering
• Validation (QEV) team and drive a culture of scientific rigor, operational excellence, and continuous improvement. If you are a hands-on technical leader with a passion for compliance, data-driven decision-making, and developing exceptional people
• this is your opportunity to make a lasting impact. What You'll Do
• Lead and inspire a team of validation engineers to ensure all systems, utilities, and manufacturing processes remain in a validated state.
• Build and reinforce a culture of excellence, collaboration, and accountability within the Quality Unit (QU).
• Oversee and approve the development and execution of IQ/OQ/PQ, process validation, and cleaning validation protocols.
• Apply statistical analysis and data-driven decision-making to monitor process performance and product consistency.
• Lead complex investigations, applying structured root cause analysis and driving CAPA implementation with measurable, sustainable results.
• Own and continuously enhance the Validation Master Plan (VMP) and validation lifecycle management systems.
• Represent McGuff during FDA inspections, customer audits, and quality reviews.
• Collaborate cross-functionally with Engineering, Manufacturing, and QA to optimize systems, processes, and inspection readiness at all times. Who You Are
• A true leader
• you mentor, motivate, and elevate others while setting uncompromising quality standards.
• A leader committed to training employees
• A strategic thinker capable of connecting long-term vision with practical implementation.
• A data-driven problem solver who uses science, logic, and disciplined analysis to drive continuous improvement.
• Comfortable leading in a regulated sterile manufacturing environment and communicating effectively with regulatory agencies. What You Bring
• A Bachelor's or Master's degree in Engineering, Life Sciences, or a related technical discipline.
• 10+ years of experience in pharmaceutical or medical device validation, including 5+ years in a leadership role.
• Hands-on expertise in aseptic process validation, equipment qualification, and computerized system validation (CSV).
• Strong command of statistical tools, process capability analysis, and trending methodologies.
• Proven proficiency in root cause analysis and CAPA management.
• In-depth knowledge of FDA, ICH, and EU GMP regulatory standards.
• Excellent communication, documentation, and presentation skills. Why McGuff
• Stable, family
• and veteran-owned company with over 20 years of proven success in sterile manufacturing.
• Leadership opportunity with clear potential for advancement and influence.
• Work directly with senior management in an organization that truly values quality above all else.
• Competitive compensation, comprehensive benefits, and a positive, mission-driven culture.

???? : employment.mpi@mcguff.com