Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
Your Role:
As a Global GxP Systems Engineer, you will be responsible for maintaining regulatory compliance of GxP computer systems and other business-managed applications throughout their lifecycle while partnering with key stakeholders (Operations, Development Services, IT, QA) to deliver key initiatives, process improvements while providing operational support to drive operational efficiencies, improve service, reduce risk and enable our employees to focus on value added tasks.
You will lead project teams across global operational departments, mentor junior team members and take ownership of GxP system lifecycle activities: including user management, configuration management, change management, SOP Management, Events/CAPAs, disaster recovery, business continuity processes, Data Integrity assessments and implementing relevant controls. You will also be responsible for identifying opportunities to improve GxP system processes and lead cross-functional teams to implement change.
Your job functions will include but not be limited to the following:
- Leading the administration of a variety of GxP systems and associated software in a regulated (GxP) environment, following defined procedures. Defining, assigning, documenting, and managing user access across CTS.
- Manage the business and IT inventory of GxP systems, ensuring compliance with business and regulatory requirements throughout the lifecycle of associated GxP systems. Contribute to the onboarding of new systems by managing GxP relevance, information classification, define service level agreements and data retention requirements of GxP systems along with supporting validation activities related to system security and data integrity for new or existing systems.
- Providing guidance and oversight for troubleshooting, incident management, servicing, maintenance, or other support functions for software or firmware associated with laboratory systems, including OS upgrades, patch management, Infrastructure management, and system security.
- Support operations as a customer by promptly addressing their escalations and providing effective solutions to resolve issues. Act as liaison between CTS operations and wider departments, ensuring clear communication and alignment on resolution strategies.
- Facilitating cross-functional meetings and bringing consensus among diverse cross-functional teams to support validation, change management, periodic review, decommissioning, and the transition of OT systems from project to operations.
- Providing leadership for the management of GxP system lifecycle activities, including but not limited to Change Management, SOP Management, Events/CAPAs, Disaster Recovery, and Business Continuity processes, Data Integrity Assessments, and implementing controls.
- Define data integrity requirements and implement solutions for GxP systems through risk assessments and requirements management.
- Identifying opportunities to improve GxP system processes and collaborating with cross-functional teams to drive change.
- Providing mentoring and guidance to junior team members and may be tasked with overseeing their work.
Who You Are:
Minimum Qualifications:
- Bachelor of Science (B.S.) or Bachelor of Arts (B.A.) degree in science or technical area.
- Proven experience in a technical role supporting regulated software applications or laboratory systems.
Preferred Qualifications:
- Minimum of 5 years of experience in regulated (GxP) environments, with experience working in the pharmaceutical or biotechnology industry strongly preferred.
- Thorough understanding of industry standards and best practices. This includes working knowledge of cGxP regulations and guidelines including: US Code of Federal Regs. 21 CFR Part 11, Part 58, Part 210 and Part 211, ICH E6 R2, ISO9001, ISO13485, Eudralex Volume 4 (Annex 11 & Annex 15), ICH Q7, Q8, Q9, Q10, GAMP 5, Computer Software Assurance (CSA) and ALCOA+.
- Experience with regulatory inspections, audits, and corrective and preventative actions related to GxP computer systems and other business-managed applications.
- Acts ethically and ensures quality of own work and that of others.
- Works with agility and willing to embrace and implement change on a global scale.
- Applies technology to drive digitalization, improve quality and increase customer value.
- Excellent communication and facilitation skills (ability to lead cross-functional meetings, demonstrated ability to bring consensus among diverse cross-functional teams).
- Proficient knowledge and application of FDA and EU regulations (cGMP, GLP).
- Advanced knowledge and application of data integrity regulatory guidance (e.g., FDA, MHRA, WHO).
- Understand quality standards for GxP software applications and systems.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
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