As a Manufacturing Support Specialist, you will be an integral part of our 24/7 manufacturing shift teams.
About the Role
* You will provide day-based support to the manufacturing teams to ensure that batch manufacture is running as intended.
* This role focuses on providing support to the shift teams to ensure that key performance indicators (KPIs) are consistently met.
Main areas of focus include:
* GMP Documentation and Right First Time Execution
* Review and close out Manufacturing Audit Readiness Training Compliance Continuous Improvement CAPA/Change control Safety OEE Organization
The successful candidate will join an organisation where people of all backgrounds and experiences are respected.
Your Key Responsibilities
1. Provide Cross Shift support to manufacturing personnel to promote best practice across 24/7 MFG shift teams.
2. Coordinate, screen and progress improvement ideas generated from the teams.
3. Lead manufacturing investigations, support continuous improvements and implement good work practices for the shift teams.
4. Manufacturing support where appropriate, providing MFG input into cross-functional teams investigating manufacturing process, environmental and water monitoring deviations.
5. Support the disposition process, managing and tracking document execution and review.
6. Participate in cross-functional project teams as applicable.
7. Identify process improvement projects and implementation and work with MT and MSAT to prioritise projects/support demands from the Business Unit.
8. Coordinate communications across the shift teams to ensure consistent communication.
9. Point of Contact for coordination of the Management of Cleaning Verification and Equipment Release.
10. Ensure compliance and Right First Time Execution, ensuring manufacturing owned investigations & change controls are raised and closed on time, recurring deviations are tracked, and that true root cause and effective CAPA are identified and implemented.
11. Support audit readiness Internal facility audits and documentation tracking.
12. Support and lead a culture of Right-First Time (RFT) through partnerships with manufacturing shift teams and provide leadership in the use of Opex principles to optimise technical and business processes.
13. Participate in HAZOPs and reviews documentation as required.
14. Support and monitor safety systems, safety audits, and monitoring behaviours and performance on shift as required and support safety communications as required.
15. Support the investigation of safety or environmental incidents on shift as required and record, report, and resolve/escalate unsafe conditions or near misses that are observed.
All duties must be performed in accordance with GMP requirements, SOPs, and controlled documents. Flexibility to take on additional tasks and responsibilities at the discretion of their manager.
Your Profile
1. Third level qualification in a Science or Engineering related subject.
2. Familiarity with Biologics manufacturing processes (Bioreactors, Chromatography, Ultra filtration, etc.) is required.
3. Experience of investigations and change controls is preferred.
4. Understanding of OEE A minimum of 3-4 years experience in large-scale Biopharmaceutical Industry.
5. Thorough knowledge of current Good Manufacturing Practices (cGMP).
Personal/Behavioural skills:
* Interpersonal / Teamwork: Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional matrix organisation essential.
* Excellent focus and attention to detail.
* Flexibility and positivity about change in a dynamic working environment.
* Excellent communication skills (including computer literacy) with the ability to develop, build, present and defend investigations/root cause analysis in both written and verbal form.
* Project management: Excellent organisational skills essential.
* Self-driven, able to handle multiple activities simultaneously, prioritising as appropriate.
* Business acumen/commercial awareness Experience in continuous improvement using Lean manufacturing tools preferred.