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 analytical equipment, facility, utilities, clean rooms, and support areas.- Assist CSV, PV, PD, MSAT and Operations teams with protocol development/review/ execution - Initiate/review/approve CAPAs, change controls, discrepancy reports, SOPs, URSs, DS/FS’s, equipment component assessments and validation plans pertaining to manufacturing and QC facilities, equipment, utilities, and processes.- Perform investigations/RCA into discrepant conditions pertaining to manufacturing facilities, equipment, utilities, and processes.- Attend client meetings as Validation representative.- Assist Engineering upper management as needed.

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 equipment, facility utilities, clean rooms, and support areas.- Initiate/review/approve CAPAs, change controls, discrepancy reports, SOPs, URSs, equipment component assessments and validation plans pertaining to manufacturing and QC facilities, equipment, utilities, and processes.- Assist CSV and Process Validation teams with protocol development/review/execution- Perform investigations into discrepant conditions pertaining to manufacturing facilities, equipment, utilities, and processes.- Attend departmental and client meetings as Validation representative.

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.- 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 pertaining to manufacturing and QC facilities, equipment, utilities, and processes.- Assist CSV and Process Validation teams with protocol development/review/execution.- Perform investigations into discrepant conditions pertaining to manufacturing facilities, equipment, utilities, and processes.- Attend departmental and client meetings as Validation representative.

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 pertaining to manufacturing and QC facilities, equipment, utilities, and processes.- Develop/Train Validation and contractor staff on equipment commissioning/qualification, protocol development, requalification program and leadership skills.- Validation Support for customer and regulatory audits.- Assist CSV and Process Validation teams with protocol development/review/execution.- Perform investigations into discrepant conditions pertaining to manufacturing facilities, equipment, utilities, and processes.- Coordinate calibration of validation equipment with the Metrology personnel.

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 reports, URSs and Validation plans pertaining to manufacturing facilities, equipment, utilities and processes. Assess impact of process, equipment or procedural changes that affect the validated state of equipment. Perform investigations into discrepant conditions pertaining to manufacturing facilities, equipment, utilities and processes. Review process flow-paths with Engineering and assist with commissioning equipment. Plan and organize validation activities amongst cross-functional groups. Provide and maintain status updates for validation activities related to day-to-day operations or project work. Coordinate calibration of validation equipment with the Metrology personnel

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 validation/calibration/PM activities with other personnel, departments and contractors. Oversee process activities in a cGMP cleanroom production area, and purification of a BLII virus used in cancer therapy. Maintain/operate filtration (tangential flow filtration) and purification (size exclusion chromatography) equipment, and various process equipment skids (egg inoculator and harvester, column controller, fill machine).

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 post-surgery treatments, and post-surgery recoveries in ICU (Intensive Care Unit).

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.