Role profile:

Take responsibility for process control systems, to be compliant with all company standards and regulatory protocols. Support production with professional, expert knowledge and maintain QMS requirements.

Role requirements:

• Responsible for the role of IT/OT for computerised equipment and participation in IT and Automation projects
• Support the development of documentation, specifications and standards for equipment at operational stage, remaining compliant with company expectations
• Maintain design documentation of equipment, including (re)validation and qualification
• Develop and review of SOPs in accordance with company goals and regulatory requirements, ensuring that equipment operates at optimal performance and organising workaround or fix if appropriate
• Support with development and implementation of maintenance strategy for equipment
• Monitor failure mode analysis, suggest improvements, investigate deviations, identify and track details of investigations, risk assessments and implement corrective actions
• Follow the SPS (Systematic Problem-Solving approach) and enforce and model this behaviour in the team
• Manage changes through the investigation cycle
• Exercising exemplary Quality mindset throughout the entire lifecycle

Your background:

• Bachelor's degree in a discipline such as: Computer Science, Information Technology, Engineering, or related.
• 3 years minimum of Engineering experience in process control systems, including automation controllers programming languages, Industrial Networking (Ethernet, Asi-bus, Profibus) and able to read and interpret technical drawings
• Demonstrable specialised training in automation and control systems
• Sound working knowledge of challenges around data integrity, information security and cyber-security
• Must be self-motivated and able to work independently, results-focused and a dedicated team-player
• Familiarity with GMP and 21 CFR Part 11 (electronic records and signatures) - a background from the pharmaceutical sector is highly advantageous
• You will be familiar with validation processes specific to pharmaceutical equipment including IQ, OQ and PQ
• Good communication skills, both in written and verbal English; collaborative and able to manage change through negotiation and influencing

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.