Designation: Empower Chromatography Data System (CDS) System Administrator
Qualification: Bachelor's Degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, Computer Science, Information Technology or a related discipline. Master's Degree is an added advantage.
Experience: Minimum 5+ years of hands-on Empower CDS Administration experience with strong chromatography instruments knowledge, GxP compliance expertise and the ability to support global laboratory operations.
Certifications: (Preferred)
- Waters Empower Administration Training/Certification.
- GxP / CSV (Computer System Validation) Certification.
- ITIL Foundation Certification.
- Pharmaceutical Quality Systems or Data Integrity related certifications are desirable.
Work Location:Remote (India) - Working in collaboration with US Service Delivery Team, supporting US Biopharmaceutical clients.
Work Timing: Complete US (PST) working hours. (IST 9:00 PM - 5:00 AM)
Client Brief: A pioneering biopharmaceutical leader, the client organization is driven by a mission to discover, develop and deliver transformative therapies that improve the lives of people around the world. With a deep focus on innovation, they have introduced groundbreaking treatments across areas such as virology, oncology and inflammation. Their trailblazing work has contributed to global advancements in HIV treatment and the fight against viral diseases. Recognized for a robust pipeline and a legacy of scientific excellence, they continuously invest in cutting-edge research and strategic partnerships. Their commitment to access, sustainability and patient-centric innovation has earned them accolades as one of the most admired and socially responsible companies in the healthcare industry.
Job Role: The Empower CDS System Administrator will be responsible for the administration, support and compliance of the Waters Empower Chromatography Data System (CDS) in a regulated laboratory environment. The role requires hands-on expertise in Empower administration, chromatography instrument integration (HPLC/UPLC/GC), user and security management, GxP compliance, Computer System Validation (CSV) and Data Integrity requirements. The individual will collaborate with Laboratory, Quality, Validation and IT teams to ensure reliable system performance, regulatory compliance and operational excellence while supporting U.S. stakeholders during full PST working hours.
Key Responsibilities:
- Administer and maintain the Waters Empower CDS environment, ensuring system availability, security and compliance.
- Configure and manage users, roles, permissions and access controls in accordance with GxP requirements.
- Support, integrate and troubleshoot HPLC, UPLC, GC and other chromatography instruments connected to Empower.
- Perform system monitoring, maintenance, upgrades, patches and periodic health checks of the Empower platform.
- Ensure compliance with FDA 21 CFR Part 11, Annex 11, ALCOA+, Data Integrity and GxP regulations.
- Execute and support Computer System Validation (CSV) activities, including IQ, OQ, PQ and change control processes.
- Investigate, troubleshoot and resolve application, instrument and data acquisition issues within defined SLAs.
- Collaborate with Laboratory, Quality, Validation and IT teams to support business-critical analytical operations.
- Maintain system documentation, SOPs, audit trails, validation records and compliance-related documentation.
- Provide end-user support, training and technical guidance while supporting stakeholders during PST working hours.
Required Skills:
- Hands-on administration experience with Waters Empower CDS (Empower 3 preferred) in a regulated pharmaceutical or life sciences environment.
- Strong knowledge of chromatography instruments (HPLC, UPLC, GC) and their integration with Empower CDS.
- Solid understanding of GxP, FDA 21 CFR Part 11, Annex 11, ALCOA+ and Data Integrity requirements.
- Experience in Computer System Validation (CSV) including IQ, OQ, PQ, risk assessments and change control.
- Proficiency in user administration, security management, access controls and audit trail management within Empower.
- Strong troubleshooting skills for CDS applications, laboratory instruments, data acquisition and system performance issues.
- Excellent communication and stakeholder management skills with the ability to support global teams during PST working hours.
Desired Skills:
- Experience with laboratory applications such as LIMS, ELN, SDMS and other GxP-regulated laboratory systems.
- Knowledge of Waters NuGenesis and its integration with chromatography and laboratory data management workflows.
- Understanding of pharmaceutical Quality Control (QC), Analytical Development and laboratory operations.
- Familiarity with ITSM tools such as ServiceNow and structured Incident, Change and Problem Management processes.
- Experience working in global pharmaceutical or biotechnology organizations supporting cross-functional and geographically distributed teams.
Personal Attributes:
- Strong ownership mindset with a high level of accountability for system reliability, compliance and support activities.
- Detail-oriented professional with a strong focus on quality, data integrity and regulatory compliance.
- Excellent problem-solving and analytical skills with the ability to troubleshoot complex technical and laboratory system issues.
- Effective communicator and collaborative team player capable of working with global stakeholders during PST business hours.5. Team player with a collaborative approach across geographies.
Pay: Up to ₹2,500,000.00 per year
Benefits:
- Provident Fund
- Work from home
Experience:
- Empower CDS (Administration & Support): 5 years (Required)
- chromatography instruments (integrate with Empower CDS): 3 years (Required)
- Data Integrity & GXP Compliance: 3 years (Required)
Shift availability:
- Overnight Shift (Required)
- Night Shift (Preferred)
Work Location: Remote
