Senior Infrastructure Architect - GxP-Regulated Environments

Job Description

We are seeking a Senior Infrastructure Architect with expertise in GxP-regulated environments to support industrial automation and IT systems. The ideal candidate will have a strong understanding of compliance, architecture frameworks, and manufacturing IT layers, particularly in relation to the Purdue Model. The candidate must be available for immediate onboarding and should be able to operate independently while advising stakeholders and driving infrastructure solutions.

Key Responsibilities:

• Design and implement infrastructure architecture for GxP-regulated environments.
• Ensure compliance with industry standards such as Good Automated Manufacturing Practice (GAMP).
• Apply Purdue Model principles to align manufacturing IT and automation layers.
• Provide expert guidance on validation, data integrity, and compliance in a regulated setting.
• Collaborate with cross-functional teams to design, optimize, and validate infrastructure solutions.
• Assess and improve IT and automation architecture to enhance operational efficiency.
• Provide advisory services on LIMS and/or Empower applications (a strong plus).
• Engage with stakeholders to ensure infrastructure solutions meet regulatory and operational requirements.

Qualifications

Mandatory Skills & Qualifications:

• Extensive experience in GxP-regulated environments, ensuring compliance with GAMP and industry standards.
• Strong understanding of the Purdue Enterprise Reference Architecture, particularly in relation to manufacturing IT and automation layers.
• Proven experience in infrastructure architecture, with the ability to design and implement solutions in complex environments.
• Senior-level expertise, with a track record of operating independently and advising stakeholders.
• Immediate availability is required.

Preferred Qualifications:

• Experience with LIMS (Laboratory Information Management Systems) and/or Empower Chromatography Data Systems.
• Background in industrial automation and IT infrastructure for regulated industries.
• Strong analytical and problem-solving skills, with the ability to navigate compliance challenges.
• Familiarity with IT/OT convergence and cybersecurity best practices within manufacturing environments.

Additional Information

At Fusion, we aspire to be one of the world's leading life sciences consulting firms, setting industry benchmarks with innovative and pioneering solutions.

At Fusion, we unite entrepreneurial minds from around the globe to develop and implement game-changing solutions that build lasting relationships with our clients.

Hiring Philosophy: We value employees who push boundaries through innovation, navigating diverse client needs in ever-evolving environments, with a commitment to continuous learning both for themselves and their colleagues.

Growth & Development: Go beyond, grow beyond, and maximize impact. Each employee shapes their own journey, and our mission is to ignite the spark of greatness while pushing the boundaries of what you are capable of. We cultivate an environment where every individual can thrive and flourish through meaningful connections, extended learning, motivation, and support to experiment with new and innovative approaches, including taking risks.

Feedback Culture: We emphasize and promote continuous, real-time feedback across all levels. We see feedback as providing individuals with the information and tools they need to develop their strengths and overcome challenges. Feedback is a gift, and inspiring individuals is our competitive advantage!

Shape you own journey - How far will you take yourself?