Global QC labs Application Engineer Manufacturing Systems

Astellas Pharma - Sanford, NC

Full-time

Remote - Sanford, NC

10,001+ employees

Management of Companies and Enterprises

About the position

The Global QC Labs Application Engineer at Astellas is a Subject Matter Expert responsible for the administration, maintenance, and enhancement of laboratory systems within a complex Scientific IT landscape. This role ensures the proper operation of GxP and non-GxP systems, providing technical support and facilitating improvements to enhance efficiency and data flow in QC labs globally. The engineer will engage in continuous learning and contribute innovative ideas to optimize project outcomes and digital capabilities.

Responsibilities

• Be the first point of contact for key users in the QC labs of the lab systems and provide technical support, triage issues and requests
• Work closely together with your direct colleagues and team members to support multiple QC labs globally
• Be the subject-matter expert for the lab systems during inspections and audits
• Be responsible for administration, maintenance and user management of lab systems such as Labware LIMS, Waters Empower and NuGenesis, Shimadzu LabSolutions, ELN and Binocs
• Facilitate and/or initiate enhancements and changes to the lab systems in close collaboration with the vendor
• Conduct training sessions to users to ensure proper use of the laboratory systems
• Regularly monitor the performance of the lab systems, identify bottlenecks, and implement optimizations to improve efficiency and user experience
• Ensure seamless integration in between the lab systems and with other business systems to enhance data flow and business processes
• Manage and ensure proper operation of GxP and non-GxP lab systems by adhering to Astellas global and local procedures and guidelines
• Work collaboratively with team members within the subdivision and across other digital and business units
• Actively participate in and contribute to various initiatives like process improvements and set up/improve the Scientific IT landscape
• Contribute to the ongoing realization of Value from these lab systems through continuous integration and deployment
• Engage in continuous learning and professional development to stay abreast of the latest trends and technologies in the specific area of expertise
• Contribute innovative ideas and approaches to enhance project outcomes and digital capabilities
• Employ analytical and problem-solving skills to overcome project challenges and deliver effective solutions

Requirements

• 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, LIMS 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
• 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
• Mandatory local language to communicate to business QC Labs and Site management

Nice-to-haves

• Agile Champion: Adherence to DevOps principles and a proven track record with CI/CD pipelines for continuous delivery
• Preferred knowledge in PL/SQL, Python and Power BI
• 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

Benefits

• Hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home
• Commitment to equality of opportunity in all aspects of employment