close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome
IE
Internet Explorer
firefox
Mozilla Firefox
opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to applications@lifescience.ie
Details

Change Control SME


Reference:SMC839543 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Channel Manager

We’re currently recruiting for an exciting opportunity with a Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


Duties

  • Technical support of vaccine drug substance and/or drug product processes to EP, including but not limited to person-in-plant support, directly within the EP manufacturing facility
  • Support Water Runs, Equipment shakedown runs, Engineering Runs, and Process Performance Qualification (PPQ).
  • Collaborate across multiple technical functions within the organisation and the EP team to ensure the successful support and commercial manufacture
  • Author process change control documentation, technical communications, and process risk management.
  • Provides technical oversight, management, and planning support for complex partnership models.
  • Provides technical guidance to the External Partner, assess viability of technology in proposed process configurations, verify adherence to required standards, and ensure deliverables are technically sound.
  • Leads team for identification and assessment of partner risks and develops mitigations plans.
  • Provides manufacturing process support to External Partner(s) to resolve production issues and to provide guidance on process and capacity optimization.
  • Support/Coordinate/Manage investigations, with appropriate interface with other impacted manufacturing sites
  • Provides a technical review of External Partner process change requests, deviations, and Master Batch Record changes.

Education & Experience
  • A Bachelor’s degree in Engineering or applicable Science is required. An advanced degree in Engineering, Science, or Business is preferred.
  • Experience in pharmaceutical manufacturing, engineering, and/or technical support of operations is required
  • Excellent leadership, collaboration, change management, interpersonal, analytical skills, collaboration, and engagement as a team player with dependable interpersonal and communication skills (both verbal and written) is required.

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.