» Computer Systems Validation Engineer - Automation

Our client is seeking to recruit a Computer Systems Validation Engineer, Automation on a permanent basis.

You will be responsible for supporting and developing the validated state of the Automation systems in use at our client’s site in line with current best practice. Provision of Computer System Validation expertise in support of existing system and new projects on site will be required.

Role Dimensions
• Reports to the Principal Automation Engineer
• Member of Automation Team (4 to 5 member staff team)
• To work at all times in line with current EHS legislation and our client’s own policies and procedures to maintain own, team and public safety
• To support the manufacturing automation systems to ensure reliability and robustness of operation and to identify, develop and implement automation changes to support Manufacturing
• Will be part of a cross functional team to support automation/IT based capital projects
• Support internal and external Quality Audits

Key Responsibilities
• Work within and develop standards and operational policies/procedures for the Automation group/systems on site
• Contribute to Automation policies and Standard Operating Procedures as required
• Produce validation documents to support Automation activities
• Ensure all automation work executed is carried out in compliance with current legislation and policy
• Identify, develop and implement approved automation changes to support Manufacturing operations
• Keep up to date on cGMP trends and practices to ensure that appropriate solutions are utilised to maximise business benefits
• Participate in various Automation capital projects (in line with the Automation Strategy) to deliver on plan and budget
Relationships

This role will chiefly support the QA and Validation departments and work with MTS, Manufacturing, Capital Projects, Maintenance and IT groups on site. The role holder will be able to:
• Understand automation validation, technology and issues.
• Communicate clearly, interpreting and explaining complex technical material / subjects to non-technical or non-expert audiences.
• Adopt a highly supportive and flexible approach to meet the needs to a variety of tasks, skill levels and backgrounds of the individuals with whom s/he will interact.

Scope and Impact
You will participate in activities that will have a positive impact on achieving team, departmental and organisational goals. Appropriate completion of projects will result in effective and safe achievement of business goals and ideas for improvement should result in savings for the organisation.


You must have:
• Automation / IT / Process Engineering qualification (Degree/HNC).
• Experience in the Pharmaceutical Industry or similar heavily regulated manufacturing environment.
• Previous experience in a similar role.
• Working knowledge of cGMP, Annex 11, 21 CFR pt 11 and GAMP 5.
• Experience of design, installation and support of Automation systems - PLC, SCADA and DCS.
• Project and system operation experience.

Suffolk | Salary range: £26,643 to 37,300
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