Medimmune is currently looking to recruit a Manufacturing engineer to be based in Liverpool. The successful applicant will be tasked in summery to provide technical leadership and focus for a Secondary Manufacturing Operation and to provide the overall management, direction and co-ordination, of all secondary engineering activities associated with the development of the site and in line with regulatory requirements, at the optimum cost and on schedule. In addition, the successful applicant will also provide vision and leadership to technical staff and manage organisational change and process improvement, where necessary. This individual will play a key contributing role in defining the values, culture, goals and growth of the site.
The role holder will be responsible for: 
  • Providing a high level of technical expertise to support the timely and effective introduction of a Secondary Manufacturing facility to successfully meet site objectives in support of corporate goals and operates within the regulatory environment
  • Provide technical leadership, direction and mentoring to ensure that the Secondary Manufacturing operation and associated projects successfully meet site objectives in support of corporate goals and operates within the regulatory environment
  • Ensuring that all Engineering & Maintenance activities are performed to EHS requirements.
  • Ensuring proactive support to ensure that the automation / process equipment performs to the highest level of reliability, repeatability within the operational expense and capital budget, whilst maintaining compliance to meet the demands of the manufacturing schedule.
  • Compilation and delivery of the training and development of both Engineering Maintenance Technicians and Manufacturing team members to improve process and equipment awareness.
  • In collaboration with the Manufacturing Leadership Team provide professional support to a demanding internal customer base, ensuring compliance with regulatory and MedImmune Quality System requirements, use of best Engineering practice and timely completion to the highest standard.
  • Collaboratively work with the Site Leadership team and corporate functions to achieve strategic product supply requirement and to contribute to the strategic objectives of the site.
  • Representing the Engineering and Maintenance department on cross functional project teams to identify and implement performance measures to be used as the basis delivering process, system and equipment improvements.
  • Participate in Regulatory Inspections (MHRA, FDA )
  • To ensure appropriate planning and delivery of Maintenance activities to meet the Manufacturing schedule within the constraints of agreed budgets.
  • Coordination and supervision of externally provided support / service contracts, including the planning, co-ordination and hosting of visiting Engineers.
  • To undertake specific projects relating to Secondary manufacturing issues, including identification and introduction of new equipment and processes.
  • Compliance & Accountability - Employees at all levels of the organisation are responsible for understanding, demonstrating and complying with the rules & requirements of the GMP Compliance Rulebook and the Code of Conduct.
*NS-Medi
*LI-MEDI


To be successful in this role, you will need to have the following background:
  • The job holder may be Chartered and shall be degree educated in either mechanical or electrical & instrumentation engineering discipline.
Experience:
  • Extensive experience in Mechanical and / or Electrical Maintenance Engineering, within a Pharma or Biotech industry.
  • The successful applicant must have people management experience of controlling visiting contractors, safe working methods and practices, the use of Permit to Work systems, including the reviewing of safe working methods and associated risk assessments.
  • Must be familiar with the operation and maintenance of plant and equipment for Pharma and / or Biotech facility, knowledge of GXP systems and practices, facility services and validation.
  • Extensive experience in a GMP environment, preferably with significant leadership experience in pharmaceutical packaging and aseptic formulation / filling operations.
  • The role holder requires a considerable awareness and understanding of Good Manufacturing Practices and HS&E requirements.
  • The role holder is likely to have held a similar managerial position
Skills and Knowledge Required:
  • The role holder will have considerable technical knowledge and high level of expertise of the job, strong mechanical and/or electrical & instrumentation aptitude and a working knowledge of mechanical, electrical and process systems, with excellent troubleshooting and diagnostic skillS
  • The role holder must have well developed interpersonal and communications skills to achieve success in their role. Time management, diplomacy, assertiveness, leadership skills and the ability to work under pressure are also essential. Appropriate degree of confidentiality and integrity must be maintained at all times.
  • Strong technical report writing and presentation skills.
  • Regulatory inspection experience is desirable
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation