IT Manufacturing Specialist

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 influencingCarbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy