- Bachelor's degree
- Master's degree
- Analysis skills
- FDA regulations
- Quality assurance
- Technical writing
- Communication skills
- Health insurance
- Vision insurance
- Dental insurance
- Paid time off
Manager Quality Engineer
90k to 115k
As the owner of all Equipment-related Quality Systems, the Senior Quality Validation Engineer will be responsible for managing a compliant validation program. The individual will lead the implementation of new equipment as well as the requalification of existing equipment per the equipment lifecycle program. Additionally, the Engineer will support (evaluate, execute, and/or oversee) validation activities for cleaning processes, facilities, utilities, and computer systems.
Manager Quality Engineer Key Responsibilities
Provide strong leadership in the coordination and execution of validation activities and related facilities operations activities while ensuring good validation practices, department operation procedures are understood, communicated and implemented by the department
Implements the overall quality strategy with respect to the validation strategy. Partners with the head of Quality Systems & Compliance and Senior Leadership Team to ensure alignment with support functions in executing the strategy.
Maintain Validation Master Plan.
Manage QAV function responsible for facility, equipment and utility validation, ensuring equipment performs suitably for its intended use, properly maintained and calibrated.
Responsible for the planning, organization, administration and general supervision of direct staff and contract personnel
Manage the validation program including performance of impact assessments, risk assessments for validation, URS procedures and forms. Acts as the lead SME for significant quality validation or compliance issues within the facility.
Oversees all aspects of QA Validation operations within the facility, including but not limited to executed equipment validation, deviation investigations, change controls, customer quality support and SOP review.
Review and approve URS and IOQ protocols as required.
Support cleaning validation activities utilized in current and future processes.
Execute area qualification, warehouse mapping, and project timelines for GMP production area(s).
Review and approve Master Equipment Files, and cGMP equipment and utilities IOQ protocols and reports.
Ownership of all equipment related deviations, CAPAs, and Change Controls
Provide validation support for site master file and other regulatory filings.
Serve as Project Manager for department initiatives and capital projects, leading the development of the budget, scope and schedule for major projects
Manages QA Validation (QAV) budget and resources to maximize efficiency and maintain quality/compliance at high levels.
Builds and maintains expertise in the QA Validation teams, including development of staff.
Manager Quality Engineer Qualifications
Bachelor’s or Master’s degree (or higher) in a scientific discipline, engineering, or a related field.
8-10 years of experience in Validation, Quality Assurance, or a technical support role in the pharmaceutical/biotech industry.
Strong communication and technical writing skills. Prior validation experience and authoring validation documents is a must. Experience managing and writing deviations, CAPA, and change controls is preferred.
Solid understanding of relevant FDA/EMA/ICH validation requirements.
Experience with QMS software.
Strong analytical, organizational, and critical thinking skills.
Ability to work in a fast-paced setting and adjust to a changing environment.
Ability to work well with diverse groups in a growing, safety focused organization
Denison offers a full benefits package that includes medical, vision and dental coverage, employee wellness programs, 401(k), paid time off and more.