Job Description

The Process Improvement Lead is accountable for providing process, technical, and operations support to the filling & blending team. This includes ongoing support of manufacturing processes. The role involves collaborating with cross-functional teams to ensure compliance, safety, and reliable supply to customers. The successful candidate will drive process improvements and ensure the continuous and reliable performance of manufacturing operations.

What you will do:

Bring energy, knowledge, and innovation to carry out the following:

• Serve as the technical and operations improvement representative for established Blend and Fill processes
• Partner with cross-functional teams, project work, process improvement, communications, and training
• Implement effective systems to identify root cause failures, make recommendations, and implement improvement changes throughout processes
• Drive continuous process improvements, aiming for optimum equipment uptime and target outputs
• Lead project-based improvement initiatives through initiation to delivery
• Develop accurate operational procedures, training materials, and manufacturing procedures
• Steer and actively participate in system failure investigations, investigation reports, execution/development of corrective actions
• Support equipment commissioning and qualification programs
• Review and approve qualification/validation documentation and studies in accordance with approval processes
• Perform data analysis and make informed decisions and recommendations based on data analysis conclusions
• Promote continuous improvement through Lean Six Sigma methodologies
• Provide technical input into quality notifications by authoring, reviewing, and approving investigations
• Participate and guide cross-functional and single-function teams
• Ensure compliance with Global Policies, Procedures, Guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP)
• Accountable for compliance through documentation completion, risk assessments, corrective action closure, participation in audits and inspections, and proactive highlighting of compliance issues

What skills you will need:

In order to excel in this role, you will more than likely have:

• Significant experience in a comparable role, adding significant value in a GMP manufacturing setting
• Knowledge of Sterile filling/blending processes and equipment, or similar
• Knowledge of regulatory requirements to UK, European, and International Standards, and Practices
• Strong report, standards, and writing skills
• Effective project management across multiple disciplines
• Proficiency in Microsoft Office and job-related computer applications
• Excellent communication, presentation, and stakeholder management skills to effectively work with colleagues
• Appreciation of the specific remit and business processes of blending & filling within Milton Keynes
• Strong change management, conflict resolution, and negotiation skills

Education

• GCSE/A Level

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Relocation:

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