This multinational pharmaceutical and biotechnology corporation is one of the largest producers of therapeutics in the world, with over 50,000 employees and revenues north of $10 billion per annum. In recent years, this market leader has expanded its footprint here in Ireland with an additional $330 million investment to their Cork site. Due to this continued expansion at this site, an exciting opportunity has arisen for an experienced CQV Engineer to join the CQV team to implement the agreed RCMF CQV strategic plan and support the CQV Lead to manage the execution of the CQV phase post project construction.
Specifically, we are looking for Process CQV Engineers with a particular focus on any of the below:
- API Batch Systems.
- API Continuous Processing Systems.
Duties and responsibilities will include:
- Ensure construction scope of works and timelines is agreed for their systems to support Green Tag system turnover.
- Familiarise themselves with their assigned systems such that they can assume ownership of all activities on their systems upon system transition from Construction to Green Tag.
- Sign permits, as system owner, for all activities on their assigned systems during the CQV phase (including pre-commissioning).
- Ensure pre-commissioning scope of works and timelines is agreed for their systems (e.g. loop check and calibration (E&I technicians), Automation engineers, M&P fitters).
- Generate all verification documentation for their assigned systems, including RAMS (Risk Assessments / Method Statements) for the verification activities.
- Ensure that all materials (e.g. spares, consumables) and resources required to undertake commissioning and verification activities are available.
- Approve SAT protocols for vendor skids within assigned systems.
- Ensure vendors RAMS (Risk Assessments / Method Statements) are approved for works to proceed.
- Execute the Verification documentation set for all assigned systems, in compliance with the schedule.
- Attend daily whiteboard meetings (run by the Area CQV Lead) and report status / progress, issues, escalations etc.
- Provide routine updates on progress per system to facilitate project reporting to the Project CQV Lead.
You should have skills and experience in the following to be considered for these opportunities:
- Minimum of 6 years relevant process experience in engineering and commissioning activities within large scale capital projects.
- Small Molecule API experience will be a distinct advantage.
- Relevant experience in leading teams in a high pace project environment.
- Experience in use of Automation systems such as Delta V.
- Experience with managing complex projects and interfacing with existing operating facilities.
- Ability to meet deadlines with good organisational and planning skills.
- Proven success working well in a team environment with flexibility to react to changing business needs.
- Excellent communicator with strong interpersonal and leadership skills with a track record of working closely with a cross functional team.
- Problem solver with a focus on achievement for overall project success.
To learn more about this role apply online or contact Pádraig Ó Luasa on + 353 87 428 0873 for a confidential discussion.