Empower System Administrator
Full-time
Insight Global
Required Qualifications:
- Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, Computer Science, or a related field
- 3+ years of experience administering Waters Empower CDS
- Experience supporting GMP-regulated pharmaceutical, biotechnology, or medical device laboratories
- Understanding of chromatography systems including HPLC and UPLC platforms
- Experience with computerized system validation and data integrity requirements
- Knowledge of 21 CFR Part 11, ALCOA+, and GxP regulations
- Experience with change controls, investigations, CAPAs, and quality systems documentation
- Strong troubleshooting, communication, and stakeholder management skills
Preferred Qualifications:
- Empower certification or advanced Empower administration training
- Experience supporting multiple laboratory informatics platforms such as LIMS, ELN, or SDMS
- Experience with Active Directory, user account management, and networked laboratory systems
- Previous involvement with large-scale laboratory system upgrades or migrations
- Experience supporting commercial pharmaceutical manufacturing operations
Job Description:
We are seeking an experienced Empower System Administrator to support laboratory operations within a highly regulated pharmaceutical manufacturing environment. This individual will serve as the subject matter expert for the Waters Empower Chromatography Data System (CDS), partnering with Quality Control, Quality Assurance, Laboratory Operations, Validation, and IT teams to ensure system performance, compliance, and data integrity.
The ideal candidate brings a combination of Empower administration expertise, GMP laboratory experience, and a strong understanding of computerized systems used in pharmaceutical testing environments.
Responsibilities:
- Serve as the primary administrator for the Waters Empower Chromatography Data System (CDS)
- Manage user accounts, permissions, security settings, and system configuration within Empower
- Support software upgrades, patches, system maintenance, and lifecycle management activities
- Partner with laboratory personnel to troubleshoot system issues and drive resolution
- Support computerized system validation activities, including qualification, testing, and documentation
- Author, review, and revise SOPs, work instructions, and technical documentation
- Support data integrity initiatives and ensure compliance with GMP, FDA, and global regulatory requirements
- Execute change controls, deviations, investigations, and CAPAs related to laboratory systems
- Collaborate with IT, automation, validation, and laboratory teams during system implementations and enhancements
- Generate reports, queries, and system metrics to support business and quality objectives
- Participate in internal and regulatory inspections as the CDS subject matter expert
Vacancy posted 4 days ago
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