Responsibilities:
· Coordinates and Supervises all C&Q activities
· Approves C&Q planning documents detailing overall strategy for the project.
· Develops and approves the master list of C&Q test documents and activities.
· Reviews and Approves all C&Q summary reports.
· Ensures the C&Q schedule is developed and maintained.
· Ensures all C&Q Engineers who perform C&Q activities have relevant training
assigned.
· Pre‐Approval and Post approval of C&Q test documents.
· Manages Daily C&Q coordination meetings.
· Responsible for Overall Tracking and Reporting of C&Q status and risks/issues.
· Ensures Startup of equipment/utilities is completed in a safe and coordinated
manner.
· Assist in the development of User Requirement Specifications (URS’s) and Quality
Risk Assessment for Equipment and Automated Systems (QRAES)
Education/Experience:
6+ years experience in Engineering or Commissioning and Qualification Management
· Technical qualification at third level or equivalent in Engineering.
· Extensive knowledge and demonstrated experience managing Commissioning and
Qualification for Pharmaceutical / Biotechnology projects
· Experience of sterile / biotech equipment within the pharmaceutical industry is
preferred.
· Knowledge of safety, GMP and environmental regulatory requirements.
· Demonstrated strong Communication and Leadership skills.
· Demonstrated ability to collaborate with senior stakeholders to achieve optimal
outcomes.
· Strong understanding of a risk‐based approach to commissioning and qualification
within the biotechnology industry
Interested candidates should submit an updated CV.
Please click the link below to apply, call William Cunnage on +353 21 4297900 or alternatively send an up to date CV to william.cunnage@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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