Our client, in West Dublin (EPCMV consultancy) is seeking to hire a number of CQV Engineers for upcoming projects (site based) across Dublin. Our client is a solutions orientated company who specialises in the life science sector, who is currently working on major capital projects across Ireland and Europe.
At present our client needs 2 - 3 CQV Engineers who are available to start new projects in the Dublin (Pharma site in Swords) region throughout July & August.
Both longterm contract and staff options on offer for engineers of suited expertise.
Role Overview
The successful Engineer’s within the C&Q team will perform cGMP compliance based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with clients. The C&Q Engineer(s) will follow client standards and requirements, overall good industry practices and regulatory requirements.
Duties & Responsibilities
- Write CQV documents following established standards and templates.
- Perform field/site activities such as: attend and witness FATs and SATs as a representative of clients, execution of commissioning forms and witnessing of vendor start-up and testing, execution of CQV protocols, walkdown and verification of system drawings.
- Compile data and prepare reports for completed CQV activities including ETOPs, protocol data packages, etc.
- Assists in deviation investigation and resolution for problems and issues encountered during field execution activities.
- Coordinate with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required.
- CQV of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
- Read, understand and utilize the Best Practices and SOPs for delivery of compliance services.
- Provide consistent, complete and timely feedback and reports to project leaders, project managers or management of project status and issues.
Qualifications & Requirements
- Bachelor of Science in Engineering is required for similar field of study.
- 3 or more years of industry experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
- Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms and protocols for GMP Utilities, Equipment, Systems, and Software is required.
- General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the EU and US FDA.
- Proficiency with Microsoft Office applications.
- Experience with Cleaning, Process, Computer System, Methods, and other validation activities and processes, beneficial.
- Experience with Risk-Based Approach to Commissioning and Qualification is beneficial.
To learn more about this opportunity please contact Daniel directly on 087-242 1331.
IND123
Job Types: Permanent, Fixed term
Contract length: 12 months
Salary: €55.00-€75.00 per hour
Benefits:
- Company events
- Employee assistance program
- Flexitime
- On-site parking
- Private medical insurance
- Wellness program
Schedule:
- Flexitime
- Monday to Friday
- No weekends
Supplemental pay types:
- Overtime pay
Education:
- Bachelor's (preferred)
Experience:
- CQV Engineering: 3 years (preferred)
- CQV of process equipment or utilities: 3 years (required)
- Pharma or Biopharma: 2 years (required)
Work authorisation:
- Ireland (required)
Work Location: In person
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