CSV Validation Engineer (Pharma/Biotech)

Responsibilities:

• Work with a cross functional team in providing Quality oversight in computerized system life cycle procedure and ensure compliance to GXP standards and company policies and procedures.
• As the Subject Matter Expert (SME) in CSV topics, provide guidance and support to establish systems for ensuring Data integrity, compliance to CSV Plan and 21CFR Part 11.
• Act as one of the key focal points for CSV topics such as deviations, change management, investigations, CAPA identification and closure and as a Subject Matter Expert
• Generate, review and execute protocols/test cases for initial validation programs related to GXP Computer systems. -e.g. Qualifications protocols – Software qualification, Input/Output loop verification, hardware qualification.
• Review and approve qualification documentations like URS, SLIA (system level impact assessment)/ CLIA (component level impact assessment), SRA (System Risk Assessment), DIRA/ DSA (Data security, audit trail review), DQ, SIOQ, HIOQ, FAT, FATSR, Traceability Matrix etc.
• Ensure adherence to CSV master plans and execution plans for GXP computer systems like DCS, PLC, BMS, MES, eBR, Lab Information systems, Environmental monitoring systems and other Business IT systems like Maximo, Network and ERP systems that are part of the GMP envelope in a Biologics manufacturing facility.
• Any other tasks assigned by Line Manager.

About You:

• Minimum bachelor’s degree or higher in Science or Engineering or equivalent with at least 3 years of relevant work experience
• Minimum 1 year experience with Emerson DeltaV system – software coding review.
• Working experience and knowledge on CSV of start-ups and brownfield project experience in both Operation Technology / Information Technology system is a plus
• Hands-on experience in Validation life cycle of computer systems is a must.
• Experience in Siemens PLC system is a plus
• Good communication skills
• Excellent team player willing to work for the common goal
• Knowledge of pharmaceutical regulatory requirements (GMP) is essential
• Shows a high level of tenacity to ensure closure of issues.
• Largely self-managed with ability to communicate upwards and cross functionally to ensure all key project milestones are met.