MSD Validation Specialist 

Ireland, Cork 

964549527

Job Description

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

• Responsible for performing the validation of equipment, utility systems, facilities, processes and/or automation systems for projects. This includes preparing protocols independently, analysing test results, and preparing technical reports.
• Troubleshoot and optimize process unit operations.
• Provide technical guidance to Operation functions.
• Participate in cross-functional problem-solving teams for troubleshooting, and investigations within Vaccines IPT.
• Contributes directly to the completion of validation projects through the development of validation schedules, master plans, validation protocols and reports for systems that may be complex in nature, to support commercial manufacturing.
• Apply Lean Six Sigma and Lean methodologies.
• Represents the department on cross-functional project teams.
• As required, assists in preparation of regulatory submissions and presents validations in respective SME areas to regulatory authorities during routine internal and pre-approval inspections.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Athird level qualification in Engineering or Science discipline.
• At least three years’ experience working as a validation specialist in the Pharmaceutical industry or a similar operating environment.
• Demonstrated knowledge of the validation requirements for equipment, computer systems and process/cleaning/steaming validation.
• Knowledge of temperature mapping, requalification requirements for equipment, periodic reviews of equipment, autoclave and SIP systems is desirable.
• Knowledge and experience of GMP and GDocP in a pharmaceutical environment.
• Excellent technical writing skills

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,please apply today.

Current Contingent Workers apply

*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.

Job Posting End Date:07/01/2024

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.