General 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 environmentsMandatory experience in CDS (Empower), LIMS (Labware) and SDMS lab systemsKnowledge of manufacturing processes, equipment qualification and computer systems validation (CSV) according to GAMP 5 principles is a must.Strong analytical and problem-solving skillsAbility to work effectively in a team environmentExcellent communication skills, both written and verbal (English (or English/Japanese for JP region)Agile and adaptable to changing environments and initiative scopesDemonstrated experience working with business to define Epics/user stories/features, as well as conducting impact analysisAble 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 systemsSupport system deliverables and provide technical and functional feedback during internal and external system auditsWork 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 upgradesLead without authority and be escalation point for any customer issuesResolve conflicts and provide mediation in service disputes between suppliers and AstellasAbility to manage critical problem and outage situations under extreme pressure
- Experience with vendor management for high value / high impact contractsExcellent people management skills over technical, service delivery and operational staffEnsure 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 deliveryPreferred knowledge in PL/SQL, Python, Qlik and DatabricksPresent 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

📌 Global Qc Labs Application Engineer (Ciudad de México)
🏢 Valce Talent Solutions
📍 Ciudad de México