**Job Title:** Global QC Labs Application Engineer – Manufacturing Systems

**Company:** Astellas Pharma Canada

**Location:** Hybrid (Primarily Poland/Japan; other locations include Netherlands/Ireland/US/Canada)

**About Us:**
At Astellas, we are a global pharmaceutical company striving to become a cutting-edge life science innovator. Our dedicated team of over 14,000 operates in approximately 70 countries, focusing on transforming innovative science into value for patients. We are proud of our achievements in oncology, overactive bladder, transplant, and our expanding pipeline in women's health, genetic regulation, and more.

**Position Overview:**
As a Global QC Labs Application Engineer, you will be the Subject Matter Expert for the administration, maintenance, and enhancements of laboratory systems. This role is vital in ensuring the proper operation of GxP and non-GxP systems in a complex Scientific IT environment.

**Responsibilities:**
- Serve as the first point of contact for key users in QC labs, providing technical support and issue triage.
- Collaborate with team members to support multiple QC labs globally.
- Act as the subject-matter expert during inspections and audits related to lab systems.
- Manage and maintain lab systems, including Labware LIMS, Waters Empower, and more.
- Facilitate enhancements and changes to lab systems in partnership with vendors.
- Conduct training sessions for users on laboratory system usage.
- Monitor lab system performance, address bottlenecks, and implement optimizations.
- Ensure integration between lab systems and other business systems to enhance data flow.
- Adhere to Astellas global and local procedures to manage GxP and non-GxP systems.
- Contribute to process improvements and advancements in the Scientific IT landscape.
- Engage in continuous learning and professional development.

**Required Qualifications:**
- Bachelor’s degree in a relevant biotech field (e.g., pharmaceutical or biotechnology).
- Minimum of 5+ years of experience in scientific IT, preferably in pharma/biotech settings.
- Mandatory experience with CDS, LIMS, and SDMS laboratory systems.
- Knowledge of manufacturing processes and computer systems validation (CSV) according to GAMP 5.
- Strong analytical and problem-solving skills.
- Excellent communication skills, both written and verbal (English; Japanese is a plus).
- Ability to adapt to changing environments and scopes.
- Experience working with business to define user stories and conducting impact analysis.
- Support system upgrades and document changes per System Life Cycle (SLC) processes.
- Collaborate with privacy and security teams to comply with applicable laws.

**Preferred Qualifications:**
- Experience with DevOps principles and CI/CD pipelines.
- Knowledge in PL/SQL, Python, and Power BI.
- Significant experience with Empower, LIMS Software, and QC Lab Solutions.

**Working Environment:**
We promote work/life balance and offer a hybrid working solution that combines time in the office with the flexibility to work from home in accordance with Astellas’ Responsible Flexibility Guidelines.

**Commitment to Diversity:**
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.

**Application:**
If your values align with our Astellas Way—patient focus, ownership, results, openness, and integrity—we would love to hear from you!