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To conduct, coordinate and manage project related activity in relation to the service, maintenance, cycle development and cycle optimisation of VHP Gassing equipment to the necessary standards in line with the overall Site Validation Master Plans for EMEA Compounding sites.
Key Results Area
Lead Improvement and Upgrade projects on VHP Gassing equipment
Project management and execution of Capital Expenditure and Process Improvement Projects for EMEA project portfolio
Optimise existing VHP Gassing cycles to enable an uplift in capacity and reduce cost
Service VHP Gassing equipment at each site within EMEA Compounding (UK, Italy, Sweden, Ireland), inclusive of proceduralising Planned and Preventative maintenance in line with the Global Compounding Reliability Centred Maintenance toolbox
Ownership in conjunction with the Country Engineering Manager’s of VHP Equipment Life Cycle Analysis and associated action planning to avoid obsolescence (future proofing)
Train local engineers to become self sufficient and therefore maintain equipment locally inclusive of planning planned and preventative maintenance
Assist Validation teams with the introduction of Enzyme Indicator technology across the EMEA Compounding network
Preparation of validation documents / protocols (VMP’s, URS, RTM, DQ, IQ, OQ & PQ) where appropriate, inclusive of execution (IQ, OQ, PQ) and report generation
Adhere strictly to regulatory, cGMP, Standard Operating Procedures, Policies & any other rules defined by the Company.
Deviation / Non- Conformance management (Including RA, RCA & CA/PA).
Identify opportunities and propose justified solutions for productivity & Quality improvements, including streamlining of processes and the use of IT-systems; and to manage their implementation.
Support Validation Leads to maintain and report on the suite of relevant Metrics and KPIs
Participating in and contributing to Baxter team projects and initiatives as required.
Knowledge & Skills
Cleanroom / aseptic manufacturing practical work
Technical understanding of cleanroom plant and associated equipment inclusive of validation and requalification
Good people, communication and computer literacy skills.
Experience of operating within maintenance and project engineering functions.
Knowledge and experience of implementation of continuous improvement activities.
Knowledge and experience of implementation of engineering best practice
QUALIFICATIONS / EXPERIENCE / KNOWLEDGE
Qualifications Required :
Degree / HND qualified in Engineering.
Project Management experience
Hands-on experience in pharmaceutical equipment maintenance and installation / commissioning.
Experience in Facilities, Equipment and Utilities project management
Experience in 6-Sigma and Lean Manufacturing - desired
Demonstrate skills in problem-solving and system design
Logical, practical-minded with a hands-on approach
Creative, analytical, innovative,
Self-motivated and able to motivate others
Shows good judgment to achieve a balance between cost V benefit, quality and safety
Able to communicate effectively, written and oral
Able to manage effectively resources and time
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.