IT / OT Support Engineer (Automation)

We are currently recruiting for an IT/OT Support Engineer (Automation Biased) to join our Operations Technology Team. This position will be based at our Wrexham site and reports directly to the Operations Technology Manager.,

• Provide automation and digital expertise to internal customers (Maintenance, Production, Quality) to ensure the availability, performance and compliance requirements of manufacturing equipment are met


• Investigate and implement improvements to manufacturing equipment


• Generate and maintain disaster recovery plans, procedures, and records for computerised systems


• Support validation activities for computerised systems (commissioning, qualification, startup)


• Generate and maintain maintenance procedures for computerised systems


• Manage minor automation projects, including:

+ Project definition and URS creation with end users
+ Management & co-ordination of project governance (e.g., schedule, costs, stakeholder management, procurement)

• Support capital projects by providing automation and digital knowledge to the Project Manager throughout the project, including:

+ Project definition and URS creation with end users
+ Leading automation and digital workstreams and tasks
+ Creation and/or coordination of design activities
+ Review of vendor designs and documents
+ Coordination of testing, installation, commissioning, and qualification

• Creation and/or coordination of handover pack, including manuals, training, standard operating procedures (SOPs), automation PPMs


• Complete quality-related activities (changes, unplanned events, CAPA) in accordance with quality-management systems


• Complete documentation to Good Documentation Practices


• Undertake training as required to maintain compliance
  
  Diagnostics and maintenance of PLC, HMI, and SCADA systems, preferably within a cGMP regulated environment



• Experience with Siemens PLC/HMI/SCADA (Step 7, WinCC Flex 20008, TIA Portal, WinCC/PCS7)


• Writing and reviewing technical documents (specifications, technical reports, risk assessments)


• Project management experience preferable (e.g., scheduling, budget control, stakeholder management, vendor liaison)


• Experience with additional PLC/HMI/SCADA manufacturers preferable


• Awareness of regulatory expectations around computerised systems (GAMP5, FDA 21 CFR11, EU ANNEX 11) preferable.


• Experience working with regulated electronic document and quality systems preferable
  
  Ipsen is a growing and dynamic specialty-driven biopharmaceutical company focussed on innovation and specialty care.


The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make a difference. We attract and develop bold, agile and entrepreneurial individuals who take full ownership of their decisions, leaders drawn by a purpose to make a direct impact through their work in people's lives, all of which is underpinned by our Ipsen Way of Being.


• We are a business that is experiencing exponential growth and change, therefore presenting a wide range of opportunities and challenges, particularly here at our Wrexham site


• A fantastic culture and working environment with many long-serving employees


• Huge commitment to Diversity & Inclusion - almost 50% of our top 160 leaders are women


• A genuine focus on the environment and sustainability - our Wrexham site is powered by 100% renewable electricity


• Competitive salaries and enhanced benefits package which includes annual bonus, generous pension scheme, wellness allowance and so much more.


• Awarded 'Best Workplaces' and 'Best Workplaces for Wellbeing' status in the Large Organisations category for 2023


• The pride of working for a company that directly impacts and changes lives for the better