PACIV
C&Q Engineer - must have valid EU Work Permit
PACIV IRE - cork, Cork, Ireland - Full Time
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
Requirements
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
