Video for this job

Collins McNicholas

The purpose of this role is to represents the Operations function and provide operational and system support to the ongoing NPI requirements of the Drug Substance Operating Unit. The breadth of this role includes working initially through detailed design & procurement and subsequently construction, commissioning, verification/qualification, and production start-up.


  • Participate in Operational Readiness Activities including Commissioning, Validation and

Verification execution and trouble shoot technical issues.

  • Responsible for right first time creation of SOP, paper batch record and other documentation, as well as all records requirements in MES or future electronic systems
  • Training of colleagues in new processes and equipment which may involve short term shift

based assignment during manufacture of NPI specific batches

  • Completion of activities detailed within the Project schedule.
  • Raise execute and manage change controls relating to NPI.
  • SME for bio-processing operations providing expertise and insight to ensure that facility design

enables safe and efficient operation and rapid product changeover to maximize facility


  • Development of innovative, new and lean method of moving from one product to another.
  • Specification and introduction of new materials and consumables for the Multi Product


  • Liaise with Tech Services, Engineering, EHS, Quality, Automation and external parties

regarding aspects of operating a Multi-Product Facility.

  • Support and lead key meetings on behalf of Operations.
  • Participation in Factory Acceptance Testing for key equipment packages (Travel may be


  • Lead/participate in risk assessment activities.
  • Develop standard work model to align with existing operations.
  • Update 5S plans to include new products requirements.



  • Diploma / Bachelors or Equivalent.
  • Familiarity of systems such as MCS, Orchestrate, MES, QTS, SAP, LIMS and PDOCs.
  • 4+ years biopharmaceutical manufacturing experience.
  • In-depth working knowledge of Biopharmaceutical processing.
  • Knowledge of cleaning validation/verification execution.
  • Experience of DS product specific equipment and materials (column resins) would be


  • Experience writing technical documents such as SOPs and batch records.
  • Experience with standard work, 5S and structured problem solving would be beneficial.
  • Excellent communications skills essential.


  • Demonstrate the GC OWNIT values
  • Adhere to all HR Policies as appropriate
  • Personal Development plans focus on the 70:20:10 guidelines
  • CI tools/- capability is a key building block for learning & development – Trained and M1


  • Proactive engagement with key stakeholders.
  • Best practices developed and shared with other teams /sites.
  • Best practices actively sought and copied.
  • Proactive & effective communication within and different functional groups in the Operating Unit.

For a confidential discussion and more information on the role, please contact Sarah Boyle on 016620088 or email

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 Temporary Contracts Blog
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