Collins McNicholas

This is a great opportinity to supervise a team of validations specialists in cold chain management responsible for review and approval of Initial and Continuing validation and qualification documentation for QA Validation (Thermal mapping of CTU’s/warehouse and shipping validation).

The sucessful candidate will be responsible for ensuring that systems and processes are qualified and/or validated in accordance with regulatory requirements and company manufacturing standards.


  • Responsible for compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.
  • Generates, executes and reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
  • May prepares equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs.
  • Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
  • Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
  • Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
  • Reviews, edits and approves change control and SOPs.
  • Collaborates with functional departments to resolve issues. 
  • May review, edit and approve HEPA certification reports, Automation performance evaluation reports, and other reports or documentation submitted to the department.
  • May train/advise less experienced Specialists and Technicians.
  • May supervise, provide direction and assign work to Validations Specialists and/or Technicians to meet goals and deadlines.
  • Assesses quality system documentation for completeness and accuracy, and dispositions documentation
  • Manages projects and prepares status reports. 
  • Interacts with Automation/Process Engineering for managing changes during qualification window.
  • Strong communication/presentation skills during internal/external audits.


  • BS/BA in Engineering, Chemistry, or Life Sciences with 6+ years of related experience within the field preferred; will substitute relevant experience for education.

For a confidential discussion on the above role please contact Michael O’Leary on 061-512270


First Name


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

5 Brilliant Benefits of Temping!

Benefits of Temping
Accepting temporary contracts can be an excellent way of earning an income. Whether you are on holidays from college or ‘in between jobs’, there are plenty of benefits to temping:   CV Regardless of how long a contract is, all jobs bring new and fresh experiences to your CV. Temping is a great way to upskill […]
Read More

Biopharma Report

biopharma biopharmaceuticals industry report
Ensuring that the supply of qualified professionals is sufficient to meet demand will be the crucial step in successfully expanding the biopharma industry in Ireland. The EGFSN (Expert Group on Future Skills Needs) estimates that 5,000 additional staff will be employed in biologics manufacturing by 2020. The number of professionals employed in the production of traditional […]
Read More
  • Find a job
  • Apply
  • Get a job