OT Project Manager

at  SimoTech

ABOUT SIMOTECH

SimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance.

QUALIFICATIONS

• 8+ years of experience managing Operational Technology (OT) projects within the life sciences industry, including pharmaceuticals, biotechnology, or medical devices.
• A proven track record in the successful delivery of complex OT projects, including automation systems, process control, and cybersecurity solutions.
• Ability to manage multiple projects and project teams simultaneously and adapt to changing priorities.
• Strong knowledge of OT systems (e.g., PLC, SCADA, DCS, MES) and their integration with IT systems.
• Familiarity with networking and cybersecurity best practices for OT environments.
• Experience with validation protocols (IQ, OQ, PQ) and GxP-compliant automation systems.
• Proficiency in project management software (e.g. Microsoft Project) and Agile or Waterfall methodologies.
• In-depth knowledge of 21 CFR Part 210/211, EudraLex Annex 11, GAMP5, and familiarity with GMP, GxP, FDA, and ISO 9001/13485 standards in validated environments.Demonstrates strong leadership, communication, and interpersonal skills, with the ability to collaborate effectively across teams, solve problems, and make decisions under pressure to deliver results.

• Lead the planning, execution, and delivery of Operational Technology projects, including automation systems, process controls, building management controls, laboratory instruments, and network infrastructure.
• Define project scope, objectives, timelines, and deliverables in collaboration with stakeholders and cross-functional teams.
• Manage the full project lifecycle, including scheduling, risk management, resource allocation, and budget oversight.
• Compile and present monthly, quarterly status reports for local and global stakeholder steering committees.
• Serve as the primary point of contact for internal teams, external vendors, and regulatory bodies, ensuring clear communication and alignment on project objectives.
• Collaborate closely with engineering, IT, quality, and validation teams to ensure seamless integration of OT systems with broader facility operations.
• Provide guidance in the design, implementation, and commissioning of OT systems, including PLC (Siemens & Rockwell), SCADA (InTouch & iFIX), DCS (PCS7), BMS (Siemens Desigo, ABB Cylon) and MES (Rockwell) platforms.
• Ensure OT systems meet operational requirements for automation, data integrity, and cybersecurity.
• Ensure all projects adhere to GxP, FDA, ISO, and other relevant regulatory standards specific to the life sciences industry.
• Identify and implement project management process and governance improvements strengthening procedures and templates for OT project delivery, focusing on efficiency, quality, and regulatory compliance.
• Lead and mentor project teams, fostering a collaborative and solution-oriented environment.Support the delivery of projects as required with creation/review/approval of documentation, test scripts and test protocols.