Sr. CSV/Principle System Specialist

SGS_JOB_3530

Information Technology
 Massachusetts
LIMS
EBR
Data Integrity
cGMP
SOPs
System Implementation
Analytical Equipment
IT Implementation

Contract - 12 Months

Location (mandatory): Westborough, MA, 01581 Small Description: The Principle System Administrator will be responsible for defining requirements for software system implementation, managing system operations, and supporting compliance with data integrity regulations (21CFR Part 11). The role focuses on LIMS and EBR platforms and will act as a key interface between Operations and IT.

Job Responsibilities:

  • Develop and maintain system configuration documentation for new products, equipment, and workflows.
  • Provide first-line troubleshooting for users.
  • Manage systems in a validated environment, develop policies and procedures for compliance.
  • Develop user requirements, configuration documents, and manage vendor IQ/OQ of equipment.
  • Develop/review SOPs, protocols, reports, and documents for supporting systems.
  • Train new users, manage system access, and ensure lab compliance with cGMP regulations.
  • Support internal/external audits and report relevant metrics.
  • Manage system updates, change controls, and maintenance activities.
  • Troubleshoot issues and assist with software system investigations and deviations.
  • Manage master data for new/existing system functionalities.
  • Ensure document compliance with protocols, SOPs, company policies, and regulations.

Skills:

  • Strong interpersonal and collaborative skills within multi-disciplinary teams.
  • Expertise in GMP, SOPs, and quality control processes.
  • Strong knowledge of quality systems and regulatory requirements.
  • Experience with the implementation and management of LIMS.
  • Strong technical writing and verbal communication skills.
  • Ability to thrive in a fast-paced team environment, multitasking effectively.
  • Self-motivated and goal-oriented with a focus on data quality.

Education/Experience:

  • B.S. in Biological Sciences, Cell Biology, Chemistry, or related field with 7+ years of experience, or M.S. with 5+ years of relevant experience.
  • Hands-on experience with a variety of analytical computerized systems.
  • Expertise in data integrity regulations and computerized systems.
  • Experience with qualification of analytical equipment.
  • Experience with electronic document management systems.
  • Knowledge of Windows OS, domains, networks, and basic lab/production computing infrastructure.

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