MSD Sr Specialist Process Engineering 

Ireland 

661303877

Job Description

Biologics INnovation Xceleration (BioNX) facility at our facility in Dunboyne.

Purpose of Role:

As a member of the Manufacturing Technologies and Engineering group, you will be responsible for the evaluation and implementation of novel equipment, innovative processes, and the implementation of next generation technologies to keep our company at the forefront of innovation in development and manufacturing of biologics. Our facility in Dunboyne serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives. Employees will feel not only that they belong in the Dunboyne, but that the facility belongs to and is shaped by them.

What you will do:

• Participate in the planning, coordination, and implementation of next generation technologies being implemented in Batch and Continuous Manufacturing by leading and supporting the:

  • Transfer of platform technologies from the earlier pipeline facilities, and bringing to GMP status locally.

  • Transfer of platform technologies to future commercial facilities.

  • Partnering within a cross-functional team to implement new technologies / software / instruments that can simplify and reduce effort around manufacturing and administrative processes, sharing with network counterparts.

  • Supporting the development of GMP Documentation such as: Risk Assessments, Batch Records, Sampling Plans, Qualification Documents, and SOPs.

  • Supporting troubleshooting and act as SME for manufacturing technology.

• Aggregate process related knowledge, and centralize for knowledge management. Maintain GMP status of responsible equipment and areas by conducing routine monitoring, calibration, maintenance, certifications as needed.

• Support the area's implementation of process changes, and root cause investigation of deviations.

• Support Weekend or On Call duty on select time frames to support manufacturing during new technology introduction.

• Own life cycle development and qualification from initiation through implementation of methods / recipes for automated equipment, integrating into the overall site DeltaV System.

• Active member of a cross-functional team managing both process and automation aspects of responsible unit operations.

• Embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environment goals.

What skills you will need:

• Bachelor’s degree in Biology, Automation, Medical Device Technologies, or Engineering.

• 6+ years of experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components)

• Familiarity with Unit Operations for biologics manufacturing.

• Competent in analyzing complex situations and show practical problem-solving capabilities.

• Equipment qualification / validation experience

• Deviation management and change control systems.

• Verbal or spoken communication skills in English.

• Ability to work independently and within a cross-functional team.

Current Contingent Workers apply

Not Applicable

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