Global QC labs Application Engineer

**Global QC labs Application Engineer**

Required Qualifications

• Bachelor’s degree in relevant biotech area (e.g. pharmaceutical- and bio technology)
• Minimum of 5+ years demonstrated experience in the scientific IT area, preferably in pharma/biotech environments
• Mandatory experience in CDS (Empower), LIMS (Labware) and SDMS lab systems
• Knowledge of manufacturing processes, equipment qualification and computer systems validation (CSV) according to GAMP 5 principles is a must.
• Strong analytical and problem-solving skills
• Ability to work effectively in a team environment
• Excellent communication skills, both written and verbal (English (or English/Japanese for JP region)
• Agile and adaptable to changing environments and initiative scopes
• Demonstrated experience working with business to define Epics/user stories/features, as well as conducting impact analysis
• Able to support technical upgrade by conducting impact assessment, addressing any issues, support testing, and document changes per the System Life Cycle (SLC) processes in Astellas.
• Maintain CMDB for each of the relevant systems
• Support system deliverables and provide technical and functional feedback during internal and external system audits
• Work closely with the internal privacy and security team to assess personal Information requests and act according per the privacy laws applicable to the region.
• Maintain and report any issues and communicate effectively to all stakeholders during project/enhancement phase, service disruptions, and during technical upgrades
• Lead without authority and be escalation point for any customer issues
• Resolve conflicts and provide mediation in service disputes between suppliers and Astellas
• Ability to manage critical problem and outage situations under extreme pressure • Experience with vendor management for high value / high impact contracts
• Excellent people management skills over technical, service delivery and operational staff
• Ensure that business and IT needs are clearly articulated for effective delivery.
• Act as system owner for relevant QC systems, responsible for keeping the systems in validated state.

Experience maintaining relationship with suppliers and maintain the relevant budgets

MUST LIMS (Labware) and SDMS lab systems

Preferred Qualifications

Agile Champion

Adherence to DevOps principles and a proven track record with CI/CD pipelines for continuous delivery

• Preferred knowledge in PL/SQL, Python, Qlik and Databricks
• Present technical and/or functional solutions based on the business requirement of the Manufacturing system.
• Significant experience in developing and configuring with Empower, LIMS Software and QC Lab Solutions

ADVANCED ENGLISH

Hybrid policy

2 days office work per week (mandatory)

Address

Avenida Santa Fe 428, Downtown Santa Fe, Tower II, Office 901, Col. Lomas de Santa Fe, Alc. Cuajimalpa de Morelos 05300, CDMX

🔴 ADVANCED ENGLISH

Hybrid policy

2 days office work per week (mandatory)

Address

Avenida Santa Fe 428, Downtown Santa Fe, Tower II, Office 901, Col. Lomas de Santa Fe, Alc. Cuajimalpa de Morelos 05300, CDMX