Mechanical Engineer & Authorised Person - Open to flexibility

Location
Hertfordshire
Salary
£Competitive
Posted
14 Mar 2017
Closes
28 Mar 2017
Ref
WD104834
Contract Type
Permanent

Mechanical Engineer & Authorised Person - Open to flexibility

Basic qualifications: 

  • Mechanical Engineering Degree

Preferred qualifications: 

  • Minimum of 5-10 years working in a pharmaceutical manufacturing or supporting process environment
  • Extensive knowledge of the site QMS and Regulatory Requirements (Safety and Quality) relative to the defined process
  • Experience in change management methodology and advocate of GPS principles
  • Exceptional influencing, leadership and decision making capabilities
  • Knowledge of historical, current and anticipated manufacturing plant and equipment.  The job holder will have sufficient scientific and engineering credibility to effectively interface with and influence key stakeholders, internal and external and through 360 deg.
  • Broad knowledge of professional engineering environment, associated disciplines, and commercial awareness.
  • Demonstrated project management competency/expertise.
  • Understanding of  basic OE and leadership principles

Details: 

We are a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. Employing close to 100,000 people globally, we have 87 manufacturing sites around the world.
Our pharmaceuticals business researches, develops and makes available medicines that treat a variety of serious and chronic diseases. We have medicines available or in development in a wide range of areas including:

  • infectious diseases 
  • cancer 
  • epilepsy 
  • heart disease 
  • asthma and chronic obstructive pulmonary disease 
  • HIV/AIDS 

Ware Manufacturing Site:

Medicines at Ware are presented as either Respiratory devices or in Oral Solid Dose form. The site holds a unique position in our network as the only site responsible for launching the company’s pipeline of new medicines in these dose forms, many of which are life saving medicines. A series of investments in new state-of-the-art equipment are being made that will support the delivery of a record number of new products. This must be achieved whilst consistently delivering outstanding quality, service and value to our patients.

Job Purpose:

Senior Mechanical Engineer & Authorised Person are responsible for leading and developing Plant and/or Equipment and/or Process understanding across the Ware Site and to manage engineers, contactors, suppliers & consultants to efficiently deliver a range of associated activities to agreed levels of quality, cost, time and tangible benefit.

To be the person responsible for a defined process/system/equipment, end to end with clear boundaries and interdependencies. This includes all tasks, systems, data and information flow required for the process/system/equipment to succeed and remain compliant. It is expected that the Authorised person be a Subject Matter Expert who has an in depth understanding of the designated process/system/equipment and has the authority and ability to do what is best for the overall performance of the process/system/equipment and ensure relevant information is fed back to the Process owner in order to make improvements to ensure delivery of the Site strategy. The Authorised person will be a point of contact in their area of expertise, for regulatory auditors during inspections.

Key responsibilities:

Facilities Engineer

  • Responsible for delivering projects and technical solutions to agreed standards, using established controls and contributing to the processes of governance .
  • Responsible for generating project proposals, designs and plans which are technically sound and give optimum investment value
  • Responsible for owning, representing  and assisting in the development of, a specific area of expertise for the site and GMS. If needed, time may be spent supporting the operations of other GSK sites.

Authorised Person

  • An Authorised person fully understands the process/system/equipment of which s/he is the owner and maintains a network of other subject matter experts with the capability to execute the process efficiently and compliantly
  • The Authorised person is required to understand all the regulatory and statutory requirements (Safety and Quality/GMP) that govern the process/system/equipment. 
  • The Authorised person is required to understand all tasks, systems and data elements that are critical to the process/system/equipment, who owns them, where they reside, who creates them and who uses them
  • The Authorised person is expected where appropriate to assist the Process Owner in Gembas, Level 1 & Level 2 audits, metrics and data to identify improvements to the process/system/equipment
  • The Authorised person must work collaboratively with other SMEs to ensure the site objectives and strategic intent are not jeopardized by individual process/system/equipment changes
  • The Authorised person must review and endorse change requests prior to their submission for approval
  • Giving agreement for the change request to proceed.
  • The Authorised person must have a full understanding of the technical implications of the change and ensure appropriate trained resource is allocated to the change
  • The Authorised person is required to notify and obtain approval from third party product owners of AL1, AL2 and AL3 changes where required. 
  • It is expected that the Authorised person will called upon to represent their area of expertise in regulatory inspections

Technical

  • Must be a recognised Authorised Person (see Ware GMS Engineering Authority Register)
  • Trained in and have a solid understanding of related GES and QMS
  • Trained in and have a solid understanding of all associated SOPs and SWI/ SWG’s

Thank you for your interest in this opportunity.

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