Department: Product Life cycle Management/Validation

Responsibilities:

• Perform Commissioning, Qualification, Validation and Re-validation activities on Equipment, Utilities, and Facility used in the Pharmaceutical Drug Manufacturing and Quality Testing in FDA approved CGMP facilities.
• Draft and review Validation Life Cycle documentation for Equipment, Utilities and Facility such as Qualification protocols [Installation Qualification (IQ)/ Operational Qualification (OQ)/ Performance Qualifications (PQ)], Specification documents such as User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Software Specifications (SS); Validation Summary reports, Deviations reports, Periodic Reviews. Author Traceability matrix and performing functional risk assessments for GMP critical requirements
• Author Traceability matrix and performing functional risk assessments for GMP critical requirements.
• Draft user requirement specifications (URS), summary reports, and traceability matrix for Cell Processing Equipment such as -20ºC Freezers, -75ºC Freezers, LN2 Freezers, Refrigerated Centrifuges, Tube Sealers, Tube Welders, Particle Counters, Nucleo-Counters, Spectrophotometer, Vi-CELL BLU, Controlled Rate Freezers, Thawing Device, Flow Cytometer, Cell Count & Viability Analyzer and Spinning Membrane Cell Washer
• Address & Draft deviations when the test results failed to meet the acceptance criteria during Installation and Operational Qualification and perform root cause investigation & impact assessment, implementing corrective actions, and documenting the justification for acceptance after implementing corrective actions.
• Perform Installation and Operational Qualification (IOQ) of Cell Processing Unit Equipment’s in Production, Warehouse/Storage Room, QC, and Bioassay.
• Participate in Aseptic Process Validation of manufacturing processes.
• Generate and execute Qualification (Installation, Operational and Performance) of Refrigerators, -20ºC Freezers, -75ºC Freezers, LN2 Freezers, Refrigerated Centrifuges, Tube Sealers, Tube Welders, Particle Counters, Nucleo-Counters, Spectrophotometer, Vi-CELL BLU, Controlled Rate Freezers, Thawing Device, Flow Cytometer, Cell Count & Viability Analyzer and Spinning Membrane Cell Washer.
• Perform 24 hours temperature mapping for Re-qualification of 2-8 ºC Refrigerators, -20ºC Freezers, -75ºC Freezers, LN2 Freezers, and CO2 Incubators using Kaye Validator (2000, AVS) (Thermocouples) and Kaye ValProbe data loggers.
• Perform Non-Viable Particle Assessment for various equipment’s in ISO7/Grade B areas such as Cell Washer and Cell Selector & Washer located in Grade B Area.
• Provide status updates on commissioning, Qualification and Validation activities for Project Management to discuss milestones and initiate brain stroming sessions on solving non-conformances that arise during validation activities.
• Perform Temperature Mapping of Controlled Temperature Units (CTU’s) utilizing Kaye Validator (2000, AVS) (Thermocouples) and Kaye ValProbe data loggers.
• Program data loggers and humidity loggers for qualification of CTU’s, Cell Production Suites, and Support Areas and Storage Room qualifications.
• Generate reports to Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems by generating reports from Equipment or Room Monitoring System (EMS/RMS) and Building Monitoring System software such as trend data (min, max, and avg) and Graphs using Info Center Software application for various parameters such as temperature, humidity and CO2%
• Perform facility qualification, static and dynamic qualifications of manufacturing room and support areas.
• Assist in the qualification of Pass Thru’s, CO2 Incubators, Refrigerated Centrifuges, Storage Room IOQ, Static and Dynamic IOQ of Cell Production Suite and Support areas.
• Provide technical expertise to define approaches and with cGMP, cGXP, CFR 21 parts 11, 210 and 211, EU annex 11, ICH Q2, Q7, Q8, Q9 and other applicable regulations, procedures and pharmaceutical industry guidance.

Educational and/or experience requirements:

• A minimum degree of bachelor’s or higher degree in Pharmaceutical Engineering or closely related
• 3-4 years experience in Adverse Event reporting
• Hands on experience with performing Commissioning, Qualification, Validation and Re-validation activities on Equipment
• Good Understanding of Pharmaceutical Manufacturing & cGMP Regulations, Pharmaceutical Engineering (Unit Operations), Chemistry and laboratory

Job Type: Full-time

Salary: $70,000.00 to $80,000.00 /year

Please send profile at info@zenithlifescience.com for direct consideration or question.

• Posted on 08/31/2022