Systems Design Engineer

We are seeking a skilled IT/OT Automation Engineer to support the delivery of critical automation and infrastructure projects within a regulated pharmaceutical manufacturing environment.

The role focuses on implementing and upgrading validated systems, ensuring compliance with GxP standards, and supporting the full system lifecycle (SDLC).

You will work at the interface between IT and Operational Technology (OT), supporting manufacturing systems that are critical to site operations.

Role Functions

(Functions include, but are not limited to, the following)

Design, develop, and maintain automation solutions for IT and OT systems

Administer and support Windows Server environments (2022 or later)

Support and integrate automated systems used in pharmaceutical manufacturing

Ensure systems comply with GxP regulations, including validation and documentation

Create and maintain GxP documentation (IQ/OQ/PQ, SOPs, risk assessments, validation plans)

Participate in and support the Software Development Lifecycle (SDLC) in a validated environment

Configure and troubleshoot network infrastructure, including understanding of VLANs, routing, switching, and firewall

• Support industrial and lab systems including:
• Rockwell FactoryTalk platforms
• Mettler Toledo FormWeigh Systems
• Environmental Monitoring Systems (EMS)Collaborate with Quality, Manufacturing, and Engineering teams to ensure system integrity and complianceWork with the Project Manager to deliver key system upgrades and executing against project plans
• Communicate progress and blockers to Project Manager and key stakeholders (IT and Business).

This is a position for IT/OT Automation Engineer, 6 months contract. Bachelor s degree is totally fine and experience working in pharmaceutical manufacturing is required, MSD highlighted that experience is superior to education, so MSD will be willing to review candidates that don t fulfill the education requirement. Most likely the interview will be held via Teams, there may be a second round of interview which will be onsite, and probably 2 people will be interviewing. Looking forward to receiving suitable candidates for the role., Demonstrated application of S88, S95, automation scope principles, competitive decision making, and MMD IT architecture standards for optimal business outcomes

Responsibilities Management of manufacturing automating projects to ensure the efforts satisfy business requirements. Responsibilities will encompass all phases of a project life-cycle including concept requirement, design, testing, installation, qualification and training. Is considered expert with many years of experience and may be a non-management level lead of a team., Experience working on system upgrades / migrations

Stakeholder management in regulated environments

Strong experience with Windows Server (2022 or later) administration

• Solid networking knowledge, including:
• VLAN configuration
• TCP/IP
• Switching and routing fundamentals
• Experience working within a GxP-regulated environment (Pharma, Biotech, Life Sciences)
• Hands-on experience with:
• GxP documentation and compliance processes
• Data Integrity - 21 CFR Part 11 / Annex 1
• System validation and lifecycle management
• Good understanding of SDLC within regulated environments
• Experience supporting or integrating:
• Rockwell FactoryTalk
• Mettler Toledo FormWeigh
• Environmental Monitoring Systems (EMS)Experience with scripting or automation tools (e.g., PowerShell)Strong analytical and problem-solving skills
• Experience with infrastructure automation tools or scripting frameworksKnowledge of virtualisation platforms (VMware)Understanding of OT cybersecurity principlesExperience working with SCADA and EMS systems

Qualifications & Education

Degree in IT, Automation, or related field (or equivalent experience)

5+ years experience delivering IT/OT or automation projects within regulated environments

Experience working in pharmaceutical manufacturing required