Global QC Labs Associate Application Engineer -Manufacturing Systems

Astellas Pharma - Sanford, NC

Full-time - Entry Level

Remote - Sanford, NC

10,001+ employees

Management of Companies and Enterprises

About the position

The Global QC Labs Associate Application Engineer at Astellas is responsible for system administration, maintenance, and enhancements of laboratory systems within a complex Scientific IT landscape. This role involves providing technical support, managing system access, and ensuring the proper operation of GxP and non-GxP systems, while contributing to the digitization and optimization of lab processes globally.

Responsibilities

• Be the first point of contact for key users in the QC labs and provide technical support.
• Work closely with colleagues in the QC labs and support QC labs globally while contributing to the digitization and optimization of lab processes.
• Be the subject-matter expert for lab systems during inspections and audits.
• Manage system access and ensure proper operation of GxP and non-GxP lab systems such as LIMS and Empower.
• Attend trainings on lab systems and technologies, and stay up to date with the latest developments in Scientific IT and digital solutions.
• 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 lab systems through continuous integration and deployment.
• 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

• Recent graduate or professional (bachelor's or master's degree) with 1 to 2 years' experience in relevant field such as Biotech, pharmaceutical sciences or Quality Control (QC) lab work.
• A strong interest in technology and curiosity about how IT processes can improve lab environments.
• Knowledge of manufacturing processes.
• Strong analytical and problem-solving skills.
• Ability to work together in a team environment.
• Excellent communication skills, both written and verbal (English or English/Japanese for JP region).
• Agile and adaptable to changing environments.
• Experience understanding and collaborating with business to define epics/user stories/features, as well as conducting impact analysis.
• Able to support technical upgrades by conducting impact assessment, addressing any issues, supporting testing, and documenting changes per the System Life Cycle (SLC) processes in Astellas.

Nice-to-haves

• Preferred knowledge in PL/SQL, Python and Power BI.
• 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 and flexibility to work from home.