Tom Leitner Email & Phone Number

Washington, DC, US

Bergisch Gladbach, North Rhine-Westphalia, DE

Dessau-Rosslau, Sachsen-Anhalt, DE

- Senior Validation SME for Equipment, Systems, Process, Utilities and Facility CQV, and client and regulatory audit support.- Senior Validation Lead for mentorship of CQV personnel.- Oversee validation contractors performing qualification activities and validated equipment/system repairs.- Develop/execute/review/approve CQV protocols for manufacturing and.

Somerset, NJ, US

- Principal Validation SME for Equipment CQV, Autoclave Qualification Program, and client and regulatory audit support.- Principal Validation Lead for CQV mentorship of Validation personnel.- Oversee validation contractors performing autoclave qualification activities.- Develop/execute/review/approve CQV protocols for manufacturing and analytical.

Somerset, NJ, US

- Oversee the daily operations of the Validation department personnel and contractors pertaining to Equipment, Utilities, and Facility CQV.- Attend departmental and client meetings as Validation representative.- Validation Lead for CQV mentorship of Validation personnel.- Perform quarterly and annual reviews for Validation engineers..

Somerset, NJ, US

- Oversee and coordinate CQV protocols for equipment and support areas.- Develop/execute/review/approve CQV protocols for manufacturing and analytical equipment, facility utilities, clean rooms, and support areas.- Initiate/review/approve CAPAs, change controls, discrepancy reports, SOPs, URSs, equipment component assessments and validation plans.

Downingtown, Pennsylvania, US

Basel, CH

SME of site sterilization and depyrogenation equipment. Oversee site equipment validation/requalification program. Write/execute/review project and system qualifications, validations, re-qualifications and revalidations of manufacturing facilities, equipment, utilities and processes. Initiate/review/approve deviations, CAPAs, change control, discrepancy.

Basel, CH

Equipment/Systems CQV, Process and Cleaning Validation

Evaluate, test, calibrate and qualify/validate the equipment and operational process systems used to develop and produce biopharmaceutical products. Establish validation standards, develop testing/qualification protocols, prepare equipment, document test results, maintain records for QA analysis and compose final reports. Coordinate.

Management of the Small Animal/Large Animal Section in Building 49 of NIH Campus, Bethesda. Daily interaction (status/progress reports) with the Contract Supervisor, NIH management, Section staff, Quality staff and Principal Investigators.Provided emergency care for the animals housed in Building 49, NIH Campus. Surgery Unit support for pre- and.

Research Triangle Park, NC, US

Coordinate and direct all study activities within an Animal Research Facility.Develop research study design, perform various DNA abnormality determination assays, and chemical preparations. Performed QA audits of toxicology/pathology data, wet tissues, slides/paraffin blocks; prepared and reviewed final audit reports.