CSV Engineer (EPKS & TPS)

Responsibilities:

• Provides expertise in performing Computerized Systems Validation.
• Primary personnel for the qualification of Computerized Systems including Automation Systems (PCS 7, EMS, MES) and GMP equipment qualifications operating within the framework of regulations (GxP, 21CFR11, etc.)
• Perform collaborative work with the Compliance Engineering team on other CQV activities.
• Coordinate with both internal and external teams (manufacturing, engineering, quality, vendors, contractors, etc.) to achieve the site objectives.
• Prepare, review, and approve of SOPs and qualification-related documentations (protocols and reports)
• Ensure that the qualification strategy is sound and adhere to company standards and regulatory requirements.
• Investigate deviations and write deviation reports and findings.
• Raise and follow-up change control records.

Requirements:

• Degree in Engineering/Science or related studies.
• Minimum of 4 years’ experience in relevant industry with at least 8 years in CSV, Quality Assurance, CQV, and Turnover Activities
• High level of understanding in Regulatory compliance
• Primarily responsible for supporting all computer validation aspects to the automation and engineering teams. This includes Domain Controller system (DCS), Manufacturing Execution system (MES), Manufacturing data warehouse (MDW), Building Automation Systems (BAS), GMP and non-GMP, Programmable Logic Controllers (PLC) based skids, IT infrastructure, standalone computerized system with equipment and validated spreadsheet.
• Familiar with working in a GxP environment and keeping up to date with current GxP, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply.
• In-depth knowledge in Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, ER/ES, validation lifecycle, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
• Good knowledge of GxP, GDP, CQV approaches including Validation Lifecycle approach (URS, DQ, FAT/SAT, IOQ, CSV, Cleaning/ Thermal Validation etc.), regulatory requirements and best industry practices.
• Works with Engineers to develop Computer Validation Strategy, plans, protocols, reports, risk assessment, requirement traceability matrix etc for any new or change induced validation system / activities.
• Develop Validation Master Plans (VMP), System Level Impact Assessments, and executed FAT, SAT, and Validation Protocols (IQ, OQ, PQ).
• Creation and/or review of validation lifecycle documents: User Requirement Specification, Functional Specification, Risk Assessments, Validation Protocols (IQ/OQ/PQ/CPV) and Reports, Study Protocols and Reports, Requirement Traceability Matrix, CFR Part 11 assessment and validation submission dossier related to CSV
• Preferred who has training or Certification in Hardware and Fieldbus communication, Batch process Operations along with EPKS & TPS