Manufacturing Support Specialist

August 26, 2024

WuXi Biologics

Dundalk

The Manufacturing Support Specialist is a key member of the manufacturing team providing continuity across the 24/7 manufacturing shift teams. This role 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

Organization Description
Wu Xi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. Our achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity, and Determination.
Wu Xi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies.

As Manufacturing Support Specialist, you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will report into the Manufacturing Associate Director (Upstream/Downstream).

Your Responsibilities
In this role, you will be responsible for:

Providing Cross Shift support to manufacturing personnel to promote best practice across 24/7 MFG shift 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.
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 consistent communication.
Point of Contact for co-ordination of 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 and documentation tracking.
Data gathering and trending where required to support process investigations.
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.
Participates in HAZOPs and reviews documentation as required.
Supports and monitors safety systems, safety audits and monitors 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 Wu Xi corporate core values and PROUD culture

Your Profile

Education:

Third level qualification in a Science or Engineering related subject

Knowledge/Experience:

Familiarity with Biologics manufacturing processes (Bioreactors, Chromatography, Ultra filtration, etc.,) is required.
Experience of investigations and change controls preferred.
Understanding of OEE
Minimum of 3-4 years’ experience in large-scale Biopharmaceutical Industry.

Thorough knowledge of current Good Manufacturing Practices (c GMP).

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
Communication Skills – 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 organizational skills essential. Self-driven, able to handle multiple activities simultaneously, prioritizing as appropriate.
Business acumen/commercial awareness – Experience in continuous improvement using Lean manufacturing tools preferred.

As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential!
If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made, and any disease can be treated - don’t miss out on this opportunity to join us and reach beyond yourself and discover your true potential.

Apply now!

Would you like to know more before you apply? Please visit us at https://www.wuxibiologicscareers.ie or contact us via talentacquisition@wuxibiologics.com

Wu Xi Biologics is an equal opportunities employer.

We regret to inform you that this job opportunity is no longer available