Configuration & Implementation Analyst MODA-EM

Role: Configuration & Implementation Analyst MODA-EM
Location; Sacramento, CA, ONSITE
Duration: 6 months

No H1B

JD:

Position Overview
The Configuration & Implementation Analyst will support the deployment of an existing MODA-EM system to an additional site. This role will focus on implementing and configuring the current MODA-EM environment, ensuring it aligns with local operational workflows while maintaining consistency with the established system architecture.
The ideal candidate will have hands-on experience with Manufacturing Execution Systems (MES) or electronic data management systems used in regulated pharmaceutical or biotechnology environments. While this role is not responsible for performing system validation, the candidate should understand computer system validation (CSV) principles and be able to support the creation and organization of validation-related documentation.

Responsibilities

MODA-EM Implementation & Configuration

• Support the rollout of an existing MODA-EM implementation at an additional site.
• Configure and implement MODA-EM modules in alignment with the current system design.
• Ensure the system supports environmental monitoring and quality workflows while maintaining consistency with the existing deployment.

Planning & Coordination

• Collaborate with internal stakeholders to support the planning and execution of the MODA-EM deployment.
• Gather and document user requirements and ensure alignment with the established system framework.

System Setup & Technical Support

• Assist with the installation, configuration, and setup of the MODA-EM system.
• Troubleshoot configuration issues and support system functionality during implementation.

Validation Documentation Support

• Support the development and organization of documentation required for computer system validation.
• Ensure implementation activities align with validation and regulatory expectations in a GxP environment.

Training & User Support

• Assist with training end users on system functionality and best practices.
• Provide ongoing support to users and help resolve system-related issues following implementation.

Qualifications

• 5+ years of experience in a pharmaceutical, biotechnology, or regulated manufacturing environment.
• Hands-on experience with MODA-EM or similar MES / electronic data management systems used in GMP environments.
• Experience supporting system implementations or configuration projects.
• Familiarity with environmental monitoring processes and laboratory/manufacturing workflows.
• Understanding of GxP regulations and computer system validation (CSV) principles.
• Ability to develop or contribute to validation documentation and implementation records.
• Strong communication skills and ability to work cross-functionally with manufacturing, quality, and IT teams.

Education



Education & Certifications:

• Bachelor's degree in Life Sciences, Engineering, Business, or a related field (Master's degree preferred).

Navnish kumar

Sr. IT Technical Recruiter

Stellent IT Phone:

Email: navnish