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Clean Systems Engineer

TRIRX SPEKE LTD

Job description

Are you a Clean Systems Engineer Seeking a new permanent career with a fantastic total reward package? Would you like to join the world’s fastest growing and largest pharmaceutical outsourcer in the animal health sector?

We are seeking a focused and energised member to our Maintenance and Reliability team. The role focus is being a key team player within engineering and applying your expertise of engineering and compliance of clean systems. You will be the custodian of processes and systems that maintain qualified state of Direct Impact equipment, facilities and utilities, specifically Controlled Temperature Storage (Temp Mapping), HVA for cleanrooms and Autocalves. You will have the ability to provide required advice to areas such as process filtration, high grade water, steam and compressed gasses.

What you will do as a Clean Systems Engineer?

• Maintain a knowledge and understanding of regulatory expectations, industry best practices and global standard relating to compliance of applicable systems

• Know and understand the fundamental theory of applicable equipment systems

• Incorporate this knowledge into governing Standard Operating Procedures

• Review updates to regulatory quality and engineering standards and develop plans to ad-dress site gaps

• Represent the site in areas requiring internal and external inspections

• Co-ordinate annual re-qualification programs and communicate standard and expectations to product and support teams

• Review qualification protocols for applicable systems

• Communicate compliance gaps/deviations to senior management

• Liaise with stakeholders to improve systems

• Participate in relevant energy reduction projects eg Clean room HVAC upgrades

• Perform regular active monitoring of clean systems to drive standards and identify safety issues

• Identify need and opportunities for improvement and work with Product teams to develop and implement solutions

• Support capital projects

• Develop user requirements for capital projects

• Define/agree commissioning and qualification requirements

• Review C&Q documents for applicable new equipment

• Be a brand advocate, demonstrating our values in all you do

What is the Essential Criteria for the role of Clean Systems Engineer

• Engineering or Science based degree

• At least 3 years experience in Pharmaceutical CGMP environments

• At least 3 years experience in HVAC systems and clean room standards

• At least 3 years experience in GMP Facility Temperature Mapping

• Formally recorded training of sterilisation principles and practises

• Prior experience of working on a COMAH site (Lower, Upper or Top)

Job type
Permanent
Industry
Engineering
Posted
2024-05-15T00:00:00

Skills

  • Engineering
  • Health-and-Safety
  • Quality