Global QC labs Application Engineer - Manufacturing Systems

At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients.

What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.

Making a positive impact on patients' lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation.

About Us:

We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.

In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative

treatments.

We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness and integrity? Then we would love to hear from you.

From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset.

Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.

Astellas Pharma Canada (APCA) is currently searching for a Global QC labs Application Engineer - Manufacturing Systems reporting to Lead MfgX Platforms.

Description:

A Global QC Labs Application Engineer is the Subject Matter Expert focused on the system administration, maintenance and enhancements to facilitate changes to laboratory systems and business processes in a complex Scientific IT landscape to ensure proper operation of GxP and non-GxP systems. Typical systems like Chromatography Data Systems (CDS), Scientific Data Management Systems (SDMS), Laboratory Information Management Systems (LIMS), Electronic Lab Notebook (ELN) and capacity management and resource scheduling systems within the Manufacturing QC labs are part of your knowledge, experience and skillset.

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 (e.g. create and manage roles, and support user access review request) 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 (e.g. LIMS and Empower) and with other business systems (e.g. LIMS with Data Lakes and ERP (SAP) 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

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 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

• 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

Preferred Qualifications:

• 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

Working Environment:

• This position is hybrid (on-site/remote) and based in Primarily Poland/Japan. Other locations: Netherlands/Ireland/US/Canada

• At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.

Category MFGX

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans