C&Q Engineer - must have valid EU Work Permit

cork, Cork, Ireland
Full Time
PACIV IRE
Experienced
Position: C&Q Engineer.   Location: Cork, Ireland.
PACIV, a global leader in industrial automation solutions with offices in Ireland, the United States and Puerto Rico, and serving the Life Science, F&B and Utilities industries, is looking for an experienced Commissioning & Qualification (C&Q) Engineer.  This is a site-based role.

Job Description
This role is a C&Q Engineer working within a multinational life science manufacturing environment in Cork, Ireland. Strong field experience working with a range of black and clean utilities is required for this role.

Responsibilities of the Role
  • The C&Q Engineer will be responsible for the development and execution of C&Q deliverables for black and field utilities for an expansion project at a life science manufacturing company.
  • Development and execution of commissioning and qualification activities within the complete system life cycle.
  • Support and coordinate the quality process over the life cycle of the projects assigned with specific focus on C&Q.
  • Commissioning and Qualification (C&Q) deliverables may include the preparation of Qualification Plan, Impact Assessment, Criticality & GMP Risk Assessments, User Requirements, Design Qualification (DQ), Traceability Matrix, Commissioning (FAT/SAT), Testing (IQ/OQ/PQ) , Quality Report, and Master Document List.
  • Detailed understanding and experience with current regulations for C&Q such as FDA cGMP’s for Risk-Based Approach and ISPE C&Q Guidelines.
  • Liaise with the various stakeholders on the overall project to ensure clear communication between all parties in relation to C&Q and project requirements.


Requirements
  • Minimum of 5 years’ strong field experience working with a range of black and clean utilities.
  • Minimum of 5 years’ experience in a similar role in life sciences, ideally in Pharmaceutical manufacturing.
  • Fluent in English, written and verbal.
  • Education:  Bachelor’s degree in engineering (Mechanical or related engineering/science studies).
  • Knowledge and experience of utilities processes and technologies.
  • Experience in development and execution of C&Q deliverables for system-development life cycle.
  • Experience with development and execution of DQ, Validation and Test Planning, Development and Execution (C&Q/CSV, IQ/OQ/PQ, Loop Checks, collate results and prepare Final Reports).
  • Works well with others, within a team and takes accountability.
  • Result driven and self-motivated.
  • Strong interpersonal and communication skills (verbal and presentation).
  • Organised, with strong computer literacy.
  • Must have valid EU Work permit and Irish Residency.
  • PLEASE NO AGENCIES




 
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