puestos de Ciberseguridad en United States

Senior Infrastructure Architect - GxP-Regulated Environments

Full-time

Swiss Delivery Excellence: Transforming Life Science Consulting Worldwide.

Fusion Consulting is a globally leading Business and IT boutique consultancy specialized in the Life Sciences industry, partnering with leading companies in pharma, healthcare, and animal health.

With over 450 employees and 25 offices worldwide, our mission is to revolutionize our clients' business transformation challenges and set new industry standards through innovative solutions.

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:

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

Mandatory Skills & Qualifications:

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

Preferred Qualifications:

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