LabVantage/Empower Implementation Specialist/Senior Business Analyst
A well-established industry leader supporting clients in the life sciences sector is seeking a Senior Business Analyst with strong experience in LabVantage LIMS and Empower. This role focuses on integrating laboratory systems, validating instrument interfaces, and ensuring compliance with industry regulations. The ideal candidate will bring a deep understanding of laboratory informatics and a proactive approach to system support and documentation.
Key Responsibilities
System Integration & Validation:
Lead the planning, development, and execution of validation deliverables for LabVantage LIMS and Empower interfaces, including URS, FS, IQ, OQ, and PQ documentation.Regulatory Compliance:
Ensure systems comply with relevant regulatory frameworks such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.Documentation & SOPs:
Maintain and review validation records, SOPs, and change control documentation to support audit readiness and system integrity.Risk Management:
Perform risk assessments to identify potential compliance issues and implement appropriate mitigation strategies.Technical Support:
Provide ongoing support for Empower users, troubleshoot technical issues, and coordinate with IT and vendors for system updates and enhancements.Training & Enablement:
Deliver training to laboratory staff and stakeholders on validated systems and ensure adherence to compliance protocols.Cross-Functional Collaboration:
Partner with QA, IT, and laboratory teams to ensure smooth integration and operation of lab systems.Change Control:
Manage and document system changes, ensuring all updates are validated and compliant with internal policies.Audit Support:
Support internal and external audits by providing validation evidence and system documentation.
Qualifications
Education:
Bachelor's degree in Life Sciences, Engineering, Computer Science, or a related field.Experience:
- 7-10 years of experience in Computer System Validation (CSV) within regulated industries such as pharmaceuticals, biotechnology, or medical devices.
- Proven experience integrating and validating LabVantage LIMS with Empower.
- Familiarity with configuring instruments in Scientific Data Management Systems (SDMS).
Technical Skills:
- Strong knowledge of GAMP 5 and 21 CFR Part 11.
- Proficiency in developing and executing IQ/OQ/PQ protocols.
- Understanding of laboratory workflows and instrument integration (e.g., HPLC, GC).
- Experience with change control, CAPA, and deviation management.
- Solid understanding of data integrity principles.
Soft Skills:
- Excellent communication and documentation skills.
- Strong attention to detail and analytical thinking.
- Ability to work independently and collaboratively in a team environment.
Additional Information
- Work Schedule: Hybrid (3 days/week on-site in Boston, MA)
- Travel: Minimal
- Benefits Include:
- Comprehensive health, dental, and vision insurance
- 401(k) with employer match
- Paid time off and holidays
- Parental leave, tuition reimbursement, and more
- Professional development opportunities
- Supportive and collaborative team culture
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