Global QC Labs Application Engineer – Manufacturing Systems

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose & Scope

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.

This role is responsible for the configuration, maintenance, integration, and support of laboratory systems to ensure compliance, efficiency, and reliability in a regulated (GxP) environment, with openness to hiring motivated individuals who are eager to learn.

Role and 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, 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 (Empower), LIMS (Labware) 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.

• Maintain CMDB for each of the relevant systems

• 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

• Resolve conflicts and provide mediation in service disputes between suppliers and Astellas

• Ability to manage critical problem and outage situations under extreme pressure

• Experience with vendor management for high value / high impact contracts

• Excellent people management skills over technical, service delivery and operational staff

• Ensure 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

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, Qlik and Databricks

• 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

Location and Working Environment

• This position is based in Sanford, NC, USA and will require on-site / Remote work.

• 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.

What awaits you at Astellas?

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.

• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.

• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.

• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organizational Values and Behaviors

Values: Innovation, Integrity and Impact sit at the heart of what we do.

Behaviors: We come together as ‘One Astellas’ , working with courage and a sense of urgency . We are outcome focused and consistently take accountability for our personal contribution.

Salary Range

$125,090 - $178,700 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations.)

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

• 401(k) match and annual company contribution

• Company paid life insurance

• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

• Long Term Incentive Plan for eligible positions

• Company fleet vehicle for eligible positions

• Referral bonus program

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Category PDM Digital

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

EOE including Disability/Protected Veterans