Senior Validation & Quality Manager

At Cumming Group, you will work on some of the world's most exciting projects in a dynamic environment where your success is measured by the impact you make. We are one of the fastest-growing project and cost management consultancies in the United States, as reflected in our top 10 rankings in ENR. With over 60 offices globally, an extremely diverse project portfolio, and double-digit year-over-year revenue growth, the opportunities to make your mark are limitless!

Cumming Group is seeking a Senior Validation & Quality Manager to address and manage GMP related deviations incurred during capital project construction activities in Class 8 & 9 environments for a Life Science client site. This role will be expected to thoroughly document all pertinent deviations and identify the root cause through a systemic analysis and determine the appropriate corrective and preventive actions. These investigations must all be conducted according to established client procedures including detailed documentation, data collection, and timely reporting.

Essential Duties & Responsibilities

• Edit and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for complex laboratory and robotic equipment.
• Perform equipment verification and validation to ensure functionality, reliability, and compliance.
• Collaborate with cross-functional teams (engineering, QA, and operations) during equipment commissioning and qualification activities.
• Prepare detailed validation reports and documentation for audits and inspections.
• Support troubleshooting and remediation activities for equipment performance issues.
• Maintain a program for preventative maintenance (PM), routine maintenance, and calibration of laboratory equipment.
• Recommend and implement changes to ensure ongoing high-quality performance of laboratory equipment.
• Perform all service activities in compliance with all relevant safety and regulatory bodies (e.g., OSHA, CAP, CLIA, etc.).
• Maintain and continuously develop knowledge and expertise related to the service of clinical laboratory equipment.
• Track all service activities utilizing system(s) developed in accordance with service procedures and laboratory policies.
• Ensure all service documentation is complete, timely, and accurate following Good Documentation Practices (GDP).
• Excellent verbal and written English communication skills.
• Adaptable, open to change, and the ability to work in ambiguous situations while responding to new information and unexpected circumstances.
• Strong interpersonal and teamwork skills; ability to easily convey concepts and priorities, as well as an ability to solicit feedback and inputs.
• Support and comply with the company’s Quality Management System policies and procedures.
• Perform other tasks as specified by the supervisor/manager
• This role works with PHI on a regular basis both in paper and electronic form and have access to various technologies to access PHI (paper and electronic) in order to perform the job
• Employees must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
• Must maintain a current status on Natera training requirements.
  
  

Knowledge & Skills Required

• Ability to analyze and problem solve issues
• Excellent attention to detail and accuracy
• Ability to promote a positive team environment
• Adaptability in a frequently changing environment
• Normally receives general instructions on routine work, detailed instructions on new projects or assignments
• Maintain a high level of professionalism and responsibility
• Must have strong communication, interpersonal and organizational skills
• Word processing and data management (MS Word, Excel, PowerPoint, etc.)
  
  

Preferred Education & Experience

Education: BS in Engineering, similar field of study, or comparable industry experience.

Experience: 5 years of quality control or validation experience in a GMP environment.

Cumming Group provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.