MSD Operations Production Specialist 

Ireland 

479196259

Job Description

The facility is designed to be operated in a multi-product mode which requires flexibility to adjust as the pipeline of clinical and commercial biologics-based medicines demands change.

Bring your energy, knowledge, and innovation to:

• The Operations Production Specialist will support end-to end production operations for both Fed Batch and Continuous Manufacturing

• Lead/Guide team members within the Production Operations team

• Coach and develop colleagues within the Production team

• Provide designee cover in the absence of the Production Manager

• Operate equipment according to electronic batch records,sampling plans and standard operating procedures.

• Responsible for monitoring operational performance, follow-up on any significant adverse trends for the identification and implementation of operational optimization, and robustness improvement projects.

• Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.

• A Change and QRA Champion within the organization and site, to bring about new technologies, digitization, and identify opportunities to bring new ways of working.

• Use the extensive operational experience to mentor new members of staff in specific plant activities when required and as a key point of contact for external groups

• Support weekend or on-call duty on select time frames to support manufacturing as POC (point of contact) and POE (point of escalation)

• Conduct all work activities with a strict adherence to the safety and compliance culture on siteSupport the Authoring of electronic batch records, sampling plans, and standard operating procedures.Support the development of GMP Documentation such as: Risk Assessments, Batch Records, Sampling Plans, Qualification Documents, and SOPs/WI’s.

What skills you will need:

• Bachelor’s degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.

• 6 years + experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components).Position level will scale with experience level of candidate.

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

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

• Understanding of multi column chromatography concepts

• Familiarity with contamination control and batch release requirements

• Experience leading, presenting, or supporting Regulatory Inspections and Site Internal Audits

• Problem, Deviation, and Change Management experience

Preferred Experience and Skills:

• Commissioning and Qualification experience

• Understanding of Upstream and Downstream Unit Operations for mAb manufacturing

• Familiarity with Emerson DeltaV, SIPAT,and the use of Automation in a manufacturing Process.

Current Contingent Workers apply

No Travel Required

Not ApplicableNot Indicated

*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.