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Confidential
Manufacturing Systems SpecialistConfidential • Louth, Louth, Ireland
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Confidential

Manufacturing Systems Specialist

Confidential
  • IE
    Louth, Louth, Ireland
  • IE
    Louth, Louth, Ireland
Jetzt Bewerben

Über

Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries.
In order to make an application, simply read through the following job description and make sure to attach relevant documents.
Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide.
The company has sites/offices in China, US, EU and Asia.
The company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies.
Job description: As a Manufacturing Systems specialist you will play a key role in establishing the Manufacturing Systems team within the Manufacturing Operations group.
The incumbent will provide expert support to the manufacturing team in the areas of SAP, LIMS, finite scheduling (Orchestrate) and benchtop equipment.
Essential Duties and Responsibilities Key member of Manufacturing Operations team in WuXi Biologics Ireland.
Provide expert support to the Manufacturing department in the areas of SAP, LIMS, Trackwise and Finite Scheduling.
Process and System owner for Manufacturing benchtop equipment.
Responsibilities in this area will include but are not limited to management of the MFG benchtop support e.g.
vendors, maintain an accurate equipment list of benchtop equipment and ensure all required system SOPs are in place.
Ensure all Manufacturing benchtop equipment are maintained in a qualified state by collaborating with relevant departments on all aspects of benchtop equipment qualification lifecycle (URS to decommissioning).
Co-ordinate vendor visits on site for bench top support, qualification and maintenance as needed.
Provide input to budget for systems.
Collaborate with MT and MSAT groups on technical transfer and process validation as required.
Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections.
Ensure that the MFG training team are supported in regards to benchtop equipment training and troubleshooting as needed.
Ensuring continual improvement of manufacturing documentation (SOPs MBRs, OJTs) for areas of responsibility to ensure they are current, accurate, and clear.
Communicate operational status regularly to senior management, as required, at the appropriate level of detail.
Assist the MFG systems lead to coordinate the work between the MFG systems groups and other functional groups to meet the production objectives and timelines.
Perform all duties in accordance with GMP requirements, SOPs and controlled documents Responsible for identifying and assessing new models of benchtop and new equipment as required.
Will be flexible to take on additional tasks and responsibilities at the discretion of the Manufacturing Operations Associate Director and Systems lead.
Support future initiatives such as electronic batch records, electronic logbooks, etc.
on behalf of Manufacturing 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 Ideally, experienced in establishing a Manufacturing department and working in a team in a greenfield context of similar size and scale.
Experience More than 2 years in biopharmaceutical manufacturing.
Experience with GMP systems such as SAP and Benchtop equipment qualification and operation etc.
Ideally have a solid understanding of quality system in terms of deviation, investigation, CAPA and change control.
Experience in working with the cross-functional teams.
Strong team lead with the demonstrated ability to manage and support manufacturing operations in a flexible and dynamic team environment.
Knowledge A proficiency in operating a drug substance commercial manufacturing facility and/or a pilot plant.
The individual need to have good understanding in DQ, FAT, SAT, IQ, OQ, & PQ (commissioning and qualification).
Knowledge of GMP systems such as SAP and Benchtop equipment qualification and operation etc.
Ideally knowledge and experience of scheduling software including Orchestrate.
Qualifications Diploma, BSc, MSc or PhD in Chemical Engineering, Bioscience, Biotechnology or Analytical Science Behavioural Competencies A strong team player with the ability to adapt to daily challenges of a manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among direct reports.
Excellent verbal and written communication and presentation skills.
Excellent interpersonal skills with the ability to work effectively with staff at all levels of the organisation.
Ability to work on own initiative and be proactive.
Results oriented, with the ability to manage multiple priorities in a short period of time.
Excellent organisational and planning skills and strong attention to detail.
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 can 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 mission
- Any drug can be made, and any disease can be treated
- dont 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? xyswxtq Please visit us at WuXi Biologics is an equal opportunities employer.
Skills: SAP LIMS TrackWise Equipment Qualification CAPA Orchestrate Biopharmaceutical Manufacturing Benefits: Bonus Life Assurance Pension VHI
TPBN1_IJ
  • Louth, Louth, Ireland

Sprachkenntnisse

  • English
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