MSD Senior Manufacturing Biotech Associate 

Ireland 

339737844

Job Description

A fantastic and exciting opportunity has arisen for a SeniorManufacturing Biotech Associateat Dunboyne Biologics, our new state of the Art single use Multiproduct Biotech facility.

The Senior Manufacturing Biotech Associate will work in a manufacturing self-directed shift team to deliver batch operations successfully, identify and resolve issues in order to allow the site to deliver for our patients in a culture that supports Quality, EHS, Learning and Continuous improvement.

What you will do:

Bring your energy, knowledge, and innovation to:

• The production of biologic drug substance on their designated shift team and will be responsible for the preparation, operation and monitoring of equipment, use of business systems and carrying out tasks including but not limited to the cleaning, validation, in-process testing.
• The progression of an automated recipe using paperless technology in order to generate the drug substance through inoculation and cell culturing activities directing to filtration and purification of the product.
• Setting up the single use equipment between runs, carrying out the production process according to world class GMP and EHS standards and driving to optimise and improve the processing activities through use of standard work and lean processing techniques.
• Focusing on delivery to the patient through living the Dunboyne culture including a commitment to safety, focusing on right first time in everything we do and concentrating on the engagement and development of self and peers.
• Participate in internal audit programs and risk assessment complianceactivity.
• Ensure incident investigations and audits are fully supported with improvement actionsimplemented.
• Coach shift teams related to RFTdocumentation.
• Lead by example through coaching and mentoring on Our Company Production systems (MPSs) skilltransfer.
• Coach CAPAs, Change actions/ SOP updates, training module development/revision related to cellarea.
• Utilise real-time data analytics for making decisions on the value stream improvementintiatives.
• Troubleshoot and resolved issues anddelays.
• Leads and participates in investigations arising from manufacturing documentation aspects whenrequired.
• Promote EHS leadership behaviours and engages employees at all levels on EHSissues.
• Promote an environment where everyone speaks up for our culture of safety and looks out for oneanother.
• Confirms that all activities have been correctly completed by the end of shift such as Real-time batch record/ SAP Comet review and elogs review.
• Be a visible leader of safety initiatives and stay actively involved in safetyforums.
• Act as a Cell Lead and be responsible for a unitoperation.
• Any other duties as and when assigned by theManager
  

What skills you will need:

• A science qualification in a technical, engineering or science-based discipline or equivalent.
• 4 years’ experience in the biotechnology and/or pharmaceutical industry or equivalent.
• Experience in a highly regulated pharmaceutical manufacturing environment.
• Good understanding in the production of biologic drug substance and experience an advantage.
• Ability to work as part of a shift team and on own initiative in a constructive manner.
• Ability to think logically and be proactive under pressure.
• Flexible and self-motivated.
• Maintain a high level of expertise and working knowledge of the processequipment.
• Can lead and deliver cross-functional Operational Excellence projects/Initiatives.
• A proven ability to work with automated systems such as Manufacturing Execution System (MES), Systems Applications and Products (SAP), Delta V etc.

So, if you are ready to:

Current Contingent Workers apply

Not Applicable

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.