Quality Validation Manager

1 week ago

Denver, United States Medical Engineering Consultants Full time

Job Purpose: Working in a team environment, the Quality Validation Manager is responsible for managing and providing oversight for projects and team members responsible for execution of validation deliverables for all local manufacturing sites, including, but not limited to equipment, utilities, facilities, cleaning, and computer systems. The manager ensures compliance with local and regulatory guidelines and requirements are met.

Job Duties & Responsibilities: Provide leadership in a fast-paced production environment with high quality and regulatory standards. Lead and develop a team of validation engineers, for personal and professional growth. Ensure the Validation Master Plan, Validation Policy, and applicable SOPs, WIs, templates, and lists reflect current practice, industry guidelines, and regulatory requirements. Work collaboratively with various departments to ensure that all required prerequisites are appropriately developed to support validation activities. Provide validation guidance as needed to assess impact to the validated status and/or product quality, and identify appropriate actions based on risk. Review and approve validation protocols and reports; assist in development and execution as needed. Coordinate with external vendors, contractors and consultants as required to ensure validation deliverables and schedules are met. Participate in audits as the Validation representative. Contribute to the development of departmental budget and monitor expenditures. Perform other related duties as assigned.

Knowledge, Skills & Abilities: Must possess proficient knowledge and understanding of regulatory guidelines and industry best practice for validation requirements within aseptic processing, clean rooms, and semi-solid manufacturing. Ability to work independently with minimal supervision. Effective organization and project management skills. Excellent oral and written communication skills demonstrated through interactions internally and externally. Ability to work well with employees at all levels. Computer literacy in Microsoft Office programs, including Outlook, Word, Access, and Excel. Effective troubleshooting and problem-solving skills. Up-to-date knowledge of cGMP regulatory issues, particularly pertaining to validation. Participate in required annual hazardous waste training. Hazardous waste involvement may include but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.

Qualifications Requirements: Bachelor’s degree in scientific or engineering discipline 8 or more years of experience in the pharmaceutical or medical device industry in quality assurance or validation 5 or more years of experience performing validation activities in an aseptic environment. Previous experience in a supervisory position preferred. A valid driver’s license and acceptable motor vehicle record may be required.

*Sponsorship/ Corp to Corp is not available for this position.

Check us out at www.medicalengineeringconsultants.com

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