LifeLink Tissue Bank has a job opportunity for a Director of Validation. This position is required to ensure compliance in all areas requiring validation (e.g. equipment, process, sterilization, packaging, etc.) and calibration. The Director of Validation will ensure the development, implementation and adherence to validation and calibration procedures.
Oversee the validation quality system & monitor department activities to identify areas for process improvement including but not limited to BF testing, log reduction studies, sterilization of tissue based products, re-useable equipment/instruments, final product packaging and cleanroom certification.
Oversee validation master plan (project based).
Management of product adoptions for tissue based products and re-useable equipment/instruments.
Provide subject matter expertise for regulatory inspections and research and development.
Participates in the management of projects to support new product development.
Review/approve validation protocols and final reports (e.g. IQ, OQ, PQ PV, etc.)
Represent validation in cross-functional meeting/projects.
Select, develop and lead personnel to ensure department objectives are met.
Management of validation project cost.
Responsible for departmental budgeting
Ensure the qualification of outside vendors used to facilitate validation and calibration activities.
Assist in developing/maintaining partner relationships.
Ensures the development and maintenance of a comprehensive environmental monitoring program: (e.g., surface testing, viable and non-viable particulate count).
Periodically report to management the status of validation activities.
Responsible to ensure the development of operating & preventive maintenance procedures for equipment.
Ensures the auditing of equipment calibrations.
Responsible for ensuring the performance of routine bioburden and dose audits related to the maintenance of the tissue irradiation validation.
Performs/provides research for development of technical and quality assurance protocols.
Ensures the maintenance of tissue being maintained for validation/research purposes.
Assists Management in areas of tissue banking research.
Work requires a Bachelor’s degree in a science related field, Masters Degree preferred.
Microbiology Laboratory experience required.
Work requires a minimum of 5 years of job related experience and minimum of 3 years leadership experience. Minimum of 5 years of cGMP/FDA regulated industry experience preferred.
Work requires strong computer, communication and writing skills.
Work requires the mental ability to analyze documentation and identify breaches in policy.
Work requires technical writing skills to prepare validation protocols and final reports.
Work requires excellent organizational skills, ability to multi-task and pay attention to detail.
Additional Salary Information: Compensation is commensurate with experience. LifeLink has a very comprehensive benefit package offered to all full-time employees. Key features: company paid pension plan, medical dental, disability and life.
Internal Number: 2019-1009
About LifeLink Foundation, Inc.
LifeLink Foundation is a non-profit community service organization dedicated to the recovery of life-saving and life-enhancing organs and tissue for transplantation therapy. The Foundation works in a sensitive, diligent, and compassionate manner to facilitate the donation of desperately needed organs and tissues for waiting patients, support research efforts to enhance the available supply of organs and tissue for transplant patients.