Manager, Computer Systems Validation

1. Serve as the QA-CSV liaison with the Engineering, Quality Control, IT and Validation organizations to support SaaS enterprise computer systems validation of Gene therapy like but not limited to Apprentice Tempo Electronic Batch Records (eBR) and Manufacturing Execution System (MES) module along with other systems integrations, Lab vantage LIMS and LES modules, Electronic Laboratory Notebook (ELN), OpenText Documentum Electronic Document Management System (EDMS), MODA Software, JDE Edwards etc.
2. Design and Software Development Life Cycle (SDLC) of the site automated systems including bioreactors, SCADA, OSISoft PI Data historian, Environmental Monitoring Systems, chromatography systems, AST Genesys Filling  semi-automated machines, autoclaves and critical utilities. Review and approve equipment/software specifications including Configuration Specification (CS), User Requirement Specification (URS), Design and Functional Requirements (DS/FRS), qualification protocols including IQ/OQ/PQ and summary reports.
3. Provide QA oversight for the site on global implementation of CSV policy and review System Impact Assessment (SIA), Data Integrity Assessments to ensure computer systems compliance with 21 CFR Part 11, Eudralex Annex 11 and applicable FDA/EMA Guidance's on electronic data integrity. 
4. Support GMP manufacturing Computer System Validation including Pall iCELLis, Cytiva, Sartorius, Thermo Fischer bioreactors, Beckam Cell counters and Repligen Tangential Flow Filtration and Sartorius Filter Integrity Testers, Wave and AKTA (Ready/Pilot) with unicon central networking systems, Sartorious Gen II/III bioreactors for use. 
5. Review and Approve lab computer systems validation documents to induct in the quality control laboratories includes PH meters, Total Organic Carbon, Double droplet PCR, Chemidoc, qPCR systems, Osmometers, Cell counters Vicell XR and Vicell Blue, Solo VPE, Bruker MALDI-TOF with Charles River database integration, Endo safe units etc.,
6. Provide QA oversight for Data Integrity Assessment for new systems as well as existing systems and its gap remediation like security, data management and disaster recovery.
7. Provide QA support for the Infrastructure qualifications that include Files Share, Networks, switches, VLAN and applications like MOveIT.  Support and maintain the validation status of the Backup, Restore, Archive Retrieval process, experience on the NAS Synology, Netback and Unitrends applications.
8. Collaborate with manufacturing, engineering, validation, QC and IT to provide training and coaching on CSV projects and data integrity initiatives; Provide input into Requirements Specifications for inclusion of Data Integrity and CSV requirements while identifying data integrity risks and propose improvement plans 
9. Serve as QA resource supporting the facility and equipment change management program, including review of applicable change controls to ensure appropriate activities are performed and documented supporting the introduction or change to equipment and facilities; Provide QA support for deviations related to Engineering, Facilities, Automation, IT, Quality Control and Validation groups. Perform Root Cause Analysis (RCA) and investigations to evaluate product impact and assist in identifying Corrective and Preventive Actions (CAPA) from the Deviations investigations.
10. Support the Risk Management Program to evaluate and mitigate risks associated with equipment and facilities as appropriate using tools such as Failure Modes Effects and Analysis (FMEA), Fault Tree Analysis (FTA) or other available risk management tools.
11. Serve as the QA-CSV resource for expansion projects which includes construction of cleanrooms, commissioning, and qualification of utilities such as HVACs, Process Gases, Water for Injection (WFI), automation systems and fill lines
12. Review and approve Standard Operating Procedures (SOPs) for the computers systems operation and administration and participate in site and corporate quality continuous process improvement initiatives; Support client and regulatory audits.

Requires a Master’s degree in Pharmaceutical Chemistry and 3 years of experience in job offered or 3 years of experience as a Senior Validation Engineer or any other job title performing the following job duties:

1. Design and Software Development Life Cycle (SDLC) of the site automated systems including bioreactors, Building Managesment, Environmental Monitoring Systems, chromatography systems, and critical utilities. Review and approve equipment/software specifications including Configuration Specification (CS), User Requirement Specification (URS), Design and Functional Requirements (DS/FRS), qualification protocols including IQ/OQ/PQ and summary reports.
2. Author, Review and Approval of  System Impact Assessment (SIA), Data Integrity Assessments to ensure computer systems compliance with 21 CFR Part 11, Eudralex Annex 11 and applicable FDA/EMA Guidance's on electronic data integrity.
3. Support GMP manufacturing  System Validation.
4. Author and Review Data Integrity Assessment for new systems as well as existing systems and its gap remediation like security, data management and disaster recovery.
5. Author review and approval of the infrastructure support systems. Support validation and maintain the validation status of the Backup, Restore, Archive Retrieval backup tools used in the disaster recovery management.
6. Collaborate with manufacturing, engineering, validation, QC and IT to provide training and coaching on CSV projects and data integrity initiatives; Provide input into Requirements Specifications for inclusion of Data Integrity and CSV requirements while identifying data integrity risks and propose improvement plans.
7. Serve as SME supporting the facility and equipment change management program, including review of applicable change controls to ensure appropriate activities are performed and documented supporting the introduction or change to equipment and facilities; Provide SME support for deviations related to Engineering, Facilities, Automation, IT, Quality Control and Validation groups. Perform Root Cause Analysis (RCA) and investigations to evaluate product impact and assist in identifying Corrective and Preventive Actions  (CAPA) from the Deviations investigations.
8. Support the Risk Management Program to evaluate and mitigate risks associated with equipment and facilities as appropriate using tools such as Failure Modes Effects and Analysis (FMEA), Fault Tree Analysis (FTA) or other available risk management tools.
9. Lead and managed commissioning and qualification of capital projects for expansion projects of cleanroom and utilities like such as HVACs, Process Gases, Water for Injection (WFI), automation systems and fill lines.
10. Review and approve Standard Operating Procedures (SOPs) for the computers systems operation and administration and participate in site and corporate quality continuous process improvement initiatives; Support client and regulatory audits.

Salary Range: $122,075.00.00 to $163,240.00/year.  Please apply online at https://www.catalent.com under Posting Number 0088945.