MSD Operations Support Specialist Downstream 

Ireland 

577813842

Job Description

Job Description

What you will do:

Bring energy, knowledge, innovation, and leadership to carry out the following:

· Managing New production introduction and product change overs

· Change Management - Change control owner for Downstream Product and Equipment Changes

· ACP, GMBR and PVL reviews

· Deviations - QN and CAPA Owner

· Subject Matter expert for Downstream equipment and process

· Troubleshooting and Technical support

· Problem Solving

· Technical reviewer for SOP's, Protocols, Studies, BOMs and DCFD's

· Monitoring of Downstream processing to ensure safety and compliance.

· Working with Automation, Engineers, and MS&T to ensure downstream processing is set-up and fully executable to support production.

· Management of the impact of changes whether through Raw Materials, Automation Recipes, MES systems and Processing Issues, etc. to assure achievement of functional metrics.

· Participate and comply with the internal Quality Management Systems, Environment, Health, and Safety System requirements.

· Drive operational excellence to deliver all components of a stable process for all commercialization milestones including pre-clinical, clinical PPQ and commercial supply.

· Be an advocate of continuous improvement in yield, cycle time, error reduction etc.

What skills you will need:

To excel in this role, you will more than likely have.

· Minimum of a bachelor’s Level 8 degree in a technical, engineering or science-based discipline or equivalent.

· At least 8 years’ experience in the BioPharma Industry with Downstream Processing experience being essential.

· Experience with new product introduction and tech. transfer would be advantageous. Proven capabilities and deep knowledge of design and operation of biologics and downstream startup and manufacturing.

· Experience troubleshooting and optimizing production processes.

· Experience with new product introductions, product change overs, Automation Systems, DCFD's and BOMs is essential.

· Knowledge of UFDF, Chromatography, VI/VF and Formulation is essential.

· Experience managing teams and projects to deliver results is essential.

· Proven record of accomplishments in a regulated industry.

· Thorough knowledge of current Good Manufacturing Practices (cGMP) and general technical and biologic operations understanding required.

So, if you are ready to:

Current Contingent Workers apply

Not Applicable

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