Collins McNicholas

Validation Engineer

Fixed Term Contract

Cork

Role Responsibilities:

  • Creation or update of SOP required for the manufacturing of a product
  • Investigation of the events that may have an impact on product quality
  • Support/generation of the annual product review for products
  • Generation or update of production batch records
  • Support the introduction of new products
  • Assist in the selection of the appropriate technologies to support the product manufacture
  • Develop SOP to support the new equipment
  • Train the operators and other personnel in the new technologies
  • Liaise/co-ordinate/support the validation activities associated with the introduction of new equipment, process or technology
  • Ensure activities are executed in line in in-house procedures and in compliance with requirements of cGMP
  • Keep up to date on regulatory development and standards by accessing in house library, accessing current Pharmacopoeias etc
  • Participation in investigation into failures, out of trends and out of specifications as required ensuring follow up, following anomalies, failures and external compliance, ensuring corrective actions are implemented
  • Be familiar with and apply the procedures, instructions, and rules of the industry and the plant
  • Be responsible for upholding QA rules
    • Ensure that SOP’s are applied
    • Record training for procedures
    • Notify QA about any deviation
    • Carry out corrective actions

Skills, Experience and Qualifications:

 

  • Third level technical qualification to degree level desirable
  • Two or more years’ experience within a GMP manufacturing environment i.e. Pharmaceutical/Chemical/Food
  • Ability to manager both projects and own routine activities
  • Provide the necessary guidance and leadership on technical projects where required
  • Good people management skills
  • Organisational and administration skills
  • Knowledge of GMP

For a confidential discussion and more information on the role, please contact Phil Burchell on 021-4911064 or email phil.burchell@collinsmcnicholas.ie

First Name

Surname

Your Email (required)

Your mobile (required)

Preferred Collins McNicholas Office (required)

Comment / Cover Letter

Upload CV

In order to provide you with our services, we need to process certain personal information about you. We will only use your personal information to deliver the job-seeking or related services you have requested.

We seek your consent to store your data and provide you with the best possible service. If you have any questions regarding our legal obligations to you or your rights under the GDPR please refer to our privacy statement which clearly outlines all of your rights.

Related Articles

Med Tech Report

A new report shows that Ireland’s medical technology sector employs over 32,000 people, hosts 18 of the 25 largest Med Tech companies in the world, and has €12.6 billion worth of exports annually, making Ireland the fifth largest exporter in Europe. Ireland develops some of the most sophisticated products in the industry, with particular strengths in high […]
Read More
  • Find a job
  • Apply
  • Get a job