Aseptic Facility Project Engineering Technician
Position: Full time
Open date: Jan 22, 2018
Functional area: Engineering
Aseptic Facility Project Engineering Technician
With the introduction of the new aseptic facility at Barnard Castle we have an exciting opportunity for highly motivated performance driven technicians to join the project team. The successful applicant will perform qualification activities and establish leading maintenance ways of working including introduction of paperless systems and eBRS. The individuals will be involved in critical equipment FAT testing and installation / qualification of equipment at the suppliers premises and within the facility at Barnard Castle. The initial work during 2018 will include installation of building services, air handling units and utility distribution systems including PCS7 automation which will be the main automation platform across the facility. The introduction of new manufacturing and aseptic processing equipment will follow in early 2019.
Whilst the roles will be initially project delivery the appointed technicians will transition into the maintenance team and operation of this world class facility using advanced maintenance systems to ensure robustness of the delivered equipment. The filling technology will be heavily automated including use of robotics so the technician's skills will be essential for robust operation of the facility and delivery of the new pipeline of Biopharmaceutical products.
These roles will commence at various stages during 2018 to meet the Project Schedule including timing for backfill appointment and training prior to release of the successful applicants.
The roles will form part of an integrated project team providing opportunity to work alongside both supplier engineers and GSK project team including representatives from Quality, Production, NPI and R&D. The roles will form part of the project delivery team who are responsible for completion of design qualification, factory acceptance testing, installation / commissioning and production readiness of the facility which will include eBRS / paperless systems.
Job Role Summary :
• Lead the engineering technical support of all equipment within the Aseptic Manufacturing Facility to highest levels of compliance for both quality and safety ensuring compliance with company standards.
• Work alongside Production, NPI and R&D to Manufacture/Fill new Biopharm Products through Development and Clinical Trial phases to end of PQ
• Work as part of an integrated team to design / implement new ways of working within the Aseptic Facility
• Ensure compliance in Engineering , Safety, Quality and Training standards.
• Ensure robust / efficient operation of the facility
• Meet Customer Service, Cost and Quality targets.
The ideal applicant will have :-
• Served a recognised engineering apprenticeship and be qualified to HNC level.
• The ability to embrace and enable change and be open to new ways of working.
• The ability to perform well as a team and individually to meet operational goals .
• A highly motivated and high energy approach to work.
• A willingness to develop new skills and build capability within yourself and the team and to work outside current comfort zones.
• Skills for rapid fault finding and capability to deliver permanent solutions to issues that may arise associated with advanced / highly automated technology where process knowledge / understanding are critical elements of the role
• A high level of computer proficiency with experience or ability to learn quickly in the Siemens PCS7/TIA Portal, Microsoft Office, CDMS & SAP. Also the ability to quickly adapt to the new Electronic Batch Record System.
• Live the GSK Values - Transparency, Respect, Integrity & Patient Focus
• Delivering work using GPS tools to maximise performance / efficiency including 5S & Zoning, Standard Work, Performance Management, Problem Solving, Gemba with Purpose and Leader Standard Work
• Proficient with engineering documentation including creating, reviewing and updating Procedures, Batch Documentation, Risk Assessments as required (e.g. SOP's, BDS, BMI, BOM, COSHH, Noise, DSEAR, Ergonomic assessments).
• Proficient in using / understanding P&ID, electrical and mechanical drawings.
• Experience of generation of live files and planed preventative maintenance routines.
• Experience of the GSK validation process including FAT/IQ/OQ document generation and execution.
Building Services Technician Roles
To be considered for these roles, ideally you will have a good working knowledge of;
• HVAC plant and equipment.
• Quality services including WFI, pure steam and gas supplies.
• Chilled water plant and equipment.
• Building management systems.
Manufacture/Fill Technician Roles
To be considered for these roles, you will have a good working knowledge of GSK products and manufacturing/fill processes within a clean room environment with experience of:
• Operating and maintaining manufacture and filling equipment.
• Experience with control systems (Siemens S7/PCS7/TIA portal ideally).
• Installation/commissioning/validation of new equipment.
• Process understanding of sterilisation equipment (Autoclaves, CIP/SIP, VHP).
These roles may require some local/international travel at short notice during the project phase and applicants must be available to travel as part of the role. Due to the project activity applicants must also have flexibility in working hours to ensure the delivery schedule is maintained.
Applications close 21st January 2018.
To apply for these role's use the 'cover letter' of the on-line application to state which role you are applying for (Building Services or Manufacture/fill Technician) and clearly describe how you meet the competencies for this role, as outlined in the job requirements above. A few lines should also be included as to why you believe you would be ideal for the role and what you think you can bring to the project.
The information that you have provided in your cover letter and CV will be used to assess your application.
Approval for application must be sought from your existing line manager before applying for this role.
Thank you for your interest in this opportunity.
You may apply for this position online by selecting the Apply now button.
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