Global Quality Control Labs Application Engineer

• 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

• 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