Job Summary

Reporting to the Manufacturing Associate Director (Upstream or Downstream), the Manufacturing Support Specialist is a key member of the manufacturing team providing continuity across the 24/7 manufacturing shift teams. This role and is responsible for providing day based support to the Manufacturing teams to ensure that batch manufacture is running as intended.

This role will focus on providing support to the shift teams to ensure that MFG reportable KPI’s are consistently met. Main area for focus will be related to the following:

• GMP Documentation – ‘Right First Time’ Execution, review and close out
• Manufacturing Audit Readiness
• Training Compliance
• Continuous Improvement
• CAPA/Change control
• Safety
• OEE

Essential Duties and Responsibilities

• The Manufacturing Support Specialist will work across all shifts to ensure a consistent approach across all the teams.
• This role will be POC for the shift teams and be responsible for coordinating, screening and progressing improvement ideas generated from the Manufacturing Shift teams.
• This will be a varied and evolving role within the Manufacturing team which may also include leading manufacturing investigations, support continuous improvements and implementing good work practices for the shift teams
• Manufacturing Support Where appropriate provide MFG input into cross-functional teams investigating manufacturing process, environmental and water monitoring deviations
• Provide Cross Shift support to manufacturing personnel to promote best practice across 24/7 MFG team.
• Support the disposition process. Manage and Track document execution and review.
• Participate in cross-functional project teams as applicable.
• Identify process improvement projects and implementation and work with MT and MSAT to priorities projects/support demands from the Business Unit.
• Coordinate communications across the shift teams to ensure a consistent message is communicated
• Support the Continuous Improvement process and drive ideas from the MFG teams to completion.
• Point of Contact for co-ordination the Management of Cleaning Verification and Equipment Release
• Compliance and Right First Time Execution Ensure 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.
• support audit readiness Internal facility audits
• Documentation tracking
• Data gathering and trending where required to support process investigations
• Manage/Update Manufacturing Documentations required.
• Participate in cross-functional project teams as applicable.
• 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 optimize technical and business processes.
• Safety Culture Performs safety audits and walk downs as required.
• Participates in HAZOPs and reviews documentation as required.
• Supports and monitors safety systems, behaviours and performance on shift as required, and supports safety communications as required.
• Supports the investigation of safety or environmental incidents on shift as required and records, reports and resolves/escalates unsafe conditions or near misses that are observed.
• Perform all duties in accordance with GMP requirements, SOPs and controlled documents
• Will be flexible to take on additional tasks and responsibilities at the discretion of their manager
• Will act as a role model for the Manufacturing function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.

Person Specification 

Technical Competencies

• Familiarity with Biologics manufacturing processes (Bioreactors, Chromatography, Ultra filtration, etc.,) is required.
• Experience of investigations and change controls preferred.
• Understanding of OEE

Experience

• Minimum of 3-4 years’ experience in a large-scale in Biopharmaceutical Industry.
• Thorough knowledge of current Good Manufacturing Practices (cGMP).
• Excellent focus and attention to detail.
• Flexibility and positivity about change in a dynamic working environment

Knowledge

• Knowledge / experience in the operation of GMP Pharmaceutical Sites would be an advantage.

Qualifications

• Third level qualification in a Science or Engineering related subject

Behavioural Competencies

• Interpersonal / Teamwork – Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional matrix organisation essential.
• Communication Skills – Excellent communication skills (including computer literacy) essential. Also the ability to develop, build, present and defend investigations/root cause analysis in both written and verbal form.
• Project management – Excellent organizational 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