At a Glance
- Tasks: Lead architectural design in a dynamic pharmaceutical manufacturing environment.
- Company: Join a transformative pharmaceutical organisation with a focus on innovation.
- Benefits: Enjoy a competitive rate, remote work flexibility, and professional growth opportunities.
- Other info: Collaborate with diverse teams and drive digital transformation initiatives.
- Why this job: Make a real impact in a highly regulated industry while working with cutting-edge technology.
- Qualifications: Proven experience in OT/IT architecture within regulated environments is essential.
Contract: 6 Months
IR35: OUTSIDE IR35
Location: REMOTE - UK
On-site: 1 day per month (North Yorkshire)
Industry: Pharmaceutical / Life Sciences
Engagement: Contract
Rate: 450pd+ Outside
The Opportunity
We are working with a pharmaceutical manufacturing organisation undergoing a significant transformation across its IT, OT, automation and digital manufacturing environment. They are looking for an experienced OT Architect to provide architectural leadership across a highly regulated pharmaceutical manufacturing environment, helping to define how IT, OT, automation, manufacturing systems, infrastructure, cybersecurity and enterprise platforms come together. This is a genuine Outside IR35 contract, offering predominantly remote working with only 1 day per month on-site.
The successful candidate will operate at an architectural level, working across both strategic and technical domains to define target-state architecture, integration patterns, technology standards, roadmaps and governance across the manufacturing environment.
Key Responsibilities
- Define and maintain the OT and site architecture vision, principles, standards, reference architectures and technology roadmaps.
- Provide architectural leadership across pharmaceutical manufacturing, including OT, automation, MES, SCADA, DCS, PLCs, historians, BMS, EMS, laboratory systems and enterprise platforms.
- Define and govern IT/OT convergence and integration architectures across manufacturing and corporate environments.
- Develop target-state architectures and practical transition roadmaps that consider production requirements, regulatory obligations, cybersecurity, resilience and lifecycle management.
- Work across platforms including MES, LIMS, QMS, WMS, ERP, EDMS, serialisation, CMMS, electronic batch records and shop-floor systems.
- Define secure and resilient architectures covering industrial networks, segmentation, DMZs, remote access, identity, infrastructure, servers, endpoints, monitoring, backup and disaster recovery.
- Assess existing OT environments to identify technical debt, obsolescence, cyber risk, unsupported technologies, architectural weaknesses, unmanaged interfaces and resilience gaps.
- Develop architecture patterns for validated and regulated manufacturing systems, including audit trails, electronic signatures, role-based access, segregation of duties, data integrity, master data, time synchronisation and lifecycle controls.
- Ensure architectural decisions support GMP, GxP, data integrity, patient safety, product quality and inspection readiness.
- Partner with Engineering, Automation, Manufacturing, Quality, Validation, Cybersecurity, Infrastructure, Data, Applications and senior site stakeholders.
- Support CSV/CSA, validation, risk assessments, design reviews, change control and regulated technology implementation.
- Lead architecture workshops, design authorities, technical reviews and supplier design assessments.
- Maintain architecture documentation including system landscapes, capability maps, data flows, integration diagrams, network/segmentation views, roadmaps and architecture decision records.
- Provide architectural input into technology investment cases, assessing business value, production impact, compliance, risk, lifecycle, scalability, supportability and total cost of ownership.
- Support digital manufacturing initiatives involving cloud, edge computing, advanced analytics, AI, automation and industrial data platforms, where appropriate for a validated environment.
- Help establish consistent architecture practices across OT, engineering, automation and technology delivery teams.
Essential Experience
We are looking for a proven OT / Industrial / Manufacturing Architect with experience operating in complex, highly regulated environments. You should have:
- Strong experience designing OT / IT architectures within pharmaceutical, life sciences, chemical, food & beverage or similarly regulated manufacturing environments.
- Strong understanding of GxP / GMP regulated environments and the implications these have on technology architecture.
- Experience with IT/OT convergence and industrial control environments.
- Strong understanding of ISA-95 and/or Purdue-style architectures.
- Practical knowledge of industrial environments including PLC, DCS, SCADA, HMI, historians, MES and industrial networks.
- Experience with OT network architecture, segmentation, industrial DMZs and secure remote access.
- Strong understanding of integration technologies including OPC UA, APIs, middleware, event-driven architecture, ETL/ELT and historian integrations.
- Experience working with validated systems and understanding of Computerised System Validation (CSV) / Computer Software Assurance (CSA).
- Strong knowledge of EU GMP Annex 11, 21 CFR Part 11, GAMP 5 and ALCOA+ / data integrity principles.
- Understanding of OT cybersecurity principles and frameworks, ideally including IEC 62443, NIST and/or ISO 27001.
- Ability to produce and communicate target-state architectures, reference architectures, roadmaps and architectural decision records.
- Excellent stakeholder management skills, with the ability to communicate effectively with engineering, automation, manufacturing, quality, cybersecurity and corporate IT.
- Experience operating in live manufacturing environments where changes must be carefully managed around production schedules, shutdowns, validation windows and batch campaigns.
Desirable
- TOGAF or equivalent Enterprise / Solution Architecture certification.
- ISA-95 / ISA-88 experience.
- IEC 62443 certification or equivalent OT cybersecurity experience.
- Experience with pharmaceutical MES / electronic batch record environments.
- Experience with LIMS, QMS, WMS, serialisation or laboratory systems.
- Experience with cloud and edge architectures within regulated manufacturing.
- Experience supporting major OT transformation, digital manufacturing or IT/OT convergence programmes.
- Previous experience working with global pharmaceutical manufacturing organisations.
Apply
If you are an experienced OT Architect, Industrial Architect, Manufacturing Architect or IT/OT Architect with a background in pharmaceutical or regulated manufacturing, we would be keen to hear from you. Please apply with your latest CV and we will be in touch to discuss the programme, rate and engagement in more detail.
GCS is acting as an Employment Business in relation to this vacancy.
OT Architect - OutsideIR35 employer: GCS
As a Social Media & Community Manager at our company, you'll thrive in a dynamic and supportive work environment that values creativity and innovation. We offer comprehensive benefits, opportunities for professional development, and a culture that encourages collaboration and open communication. Located in a vibrant area, our team enjoys a unique blend of work-life balance and community engagement, making it an excellent place to grow your career while making a meaningful impact.
StudySmarter Expert Advice🤫
We think this is how you could land OT Architect - OutsideIR35
✨Get Familiar with Temporary Roles in Pharma
Temporary positions in the pharmaceutical industry often arise during specific periods, like product launches or seasonal hiring sprints. Keep an eye on timelines and be proactive in reaching out to companies, especially around these busy times!
✨Join Pharma Networking Events
Participate in local and virtual pharmaceutical networking events or job fairs. This is a fantastic way to get in front of hiring managers and learn more about temporary opportunities directly from those in the know.
✨Leverage Your University Career Services
If you’re a student or recent grad, tap into your university’s career services which often have specific connections to pharma companies looking to fill temporary roles. They might even have exclusive internship programmes that lead to temp jobs!
✨Be Visible Online and Offline
Utilise platforms like LinkedIn to share your interests in temporary roles and connect with industry professionals. Plus, consider writing about relevant pharmaceutical topics to showcase your knowledge and enthusiasm—this can help you stand out to hiring companies like GCS.
We think you need these skills to ace OT Architect - OutsideIR35
Some tips for your application 🫡
Highlight Your Relevant Experience:In the pharmaceutical industry, it's crucial to showcase any relevant experience you have, whether it's internships, lab work, or coursework. Let’s emphasise your familiarity with drug development processes and any hands-on experience you've had with lab equipment or clinical trials in your CV.
Mention Certifications and Training:If you’ve got any certifications relevant to pharmaceuticals, like Good Clinical Practice (GCP) or a certification in pharmacovigilance, make sure to include them. These show your commitment to the field and can make a positive impact on your application for a temporary role at GCS.
Show Your Flexibility and Availability:Temporary positions often require immediate availability and flexibility in working hours. In your cover letter, make it clear when you can start and your ability to adapt to changing schedules, as this is key to a successful application.
Express Your Learning Goals:Since this is a temporary role, we suggest discussing what you hope to learn or gain from the experience at GCS. This not only shows your eagerness but also helps employers see you as someone who’s ready to make the most out of the opportunity.
How to prepare for a job interview at GCS
✨Know Your Regulations
In the pharmaceutical industry, it’s crucial to understand key regulations like GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices). Brush up on these standards and be ready to discuss how they influence your work approach during your interview with GCS.
✨Emphasise Adaptability
Since this is a temporary role, show that you're ready to hit the ground running. Share examples from your past experiences that demonstrate your ability to adapt quickly to new environments or changes, especially in a fast-paced setting like pharmaceuticals.
✨Highlight Relevant Skills and Tools
Whether it’s laboratory techniques or software like LabWare or SAS, make sure you can confidently talk about your technical skills. If you have experience with any specific tools used in previous roles, relate that directly to how it can help GCS achieve its goals.
✨Prepare for Technical Questions
Be ready for technical questions related to drug development processes or quality assurance. We should expect scenarios where you might have to troubleshoot a problem or suggest improvements on a project—this shows your problem-solving capability in a temporary role.
