Our client has an exciting opportunity for an established Project Engineer
Our client has an exciting opportunity for a permanent Project Engineer. Reporting to the Projects Manager, the person will have the opportunity to work as a Project Engineer on the site's current and future project portfolio including serialisation, potent material processing, automation and MES along with sustainability focused programmes.
The successful candidate will be responsible for managing the scope cost and schedule of the projects assigned to them and will be responsible for delivering the projects on time and within budget.
The following is a non-exhaustive list expressing the main responsibilities, duties and tasks associated with the role:
- Continuation and implementation of serialisation requirements as new countries come on board
- Installation, Commissioning, and validation of manufacturing plant and processes, troubleshooting and debug of equipment under the site change control system
- Lead the generation of lifecycle documentation for process equipment and associated systems.(URS, FDS, DDS, FAT, SAT, IQ/OQ, Risk Assessments, procedures etc)
- Support project management through Factory Acceptance Testing, Commissioning, Qualification, etc.
- Ensure Projects are handed over in a controlled manner with manuals, training maintenance systems and site master drawings updated
- Optimisation of new and existing processes to achieve production output targets.
- Provide routine technical support for assigned process and packaging activities.
- The ideal candidate will have experience in implementing MES programmes
- Generating necessary departmental documents e.g. SOP's
- Reporting on status of CAPEX program on a monthly basis to include adherence to budget, schedule and man hours
- Assisting the Projects function and/or designates in all assigned projects.
- Review line metrics and provide technical solutions to increase operational efficiency.
- Collaborate significantly with internal/external functions and suppliers to finalize process and equipment design.
- Follow cGMP guidelines, safety procedures, and SOPs at all times
The successful candidate will have graduated with a minimum of Level 8 qualification in Engineering and will possess the following Knowledge, Skills and Experiences:
- Level 8 degree in Engineering, preferably Chemical or Mechanical
- A minimum of 5 years' experience working as a project engineer/project management working on biopharma projects with a demonstrated record of on time project performance to budget
- The ideal candidate must have worked in serialisation and the serialising/aggregation process. The candidate should have experience in the complete serialisation process at all levels including management of serial number definitions and formats and integration of serialisation procedures into departmental systems for associating serial numbers with orders, shipments, invoices etc.
- Experience of managing the financial performance of engineering projects
- Experience in construction and packaging projects also essential
- Previous experience in working within a high containment environment a distinct advantage
- Previous experience in MES implementation a distinct advantage
- Highly effective people management skills - Experience of managing engineers at all levels along with cross functional teams and external service providers
- Excellent time management and organisational skills- Must be well organised in approach to work and disciplined in the evaluation of priorities and reaction to same.
- Must be able to thrive in an environment where there can be simultaneously many number one priorities
- Logical and analytical problem solving skills (a solution provider rather than a problem provider)
- Excellent communication skills, both oral and written along with an ability to communicate ideas, concepts and projects clearly and positively
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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