CQV Engineer (Senior)
Independent Solutions
- Dublin
- Contract
- Full-time
Overview:
Commissioning and Qualification (C&Q) engineer for various capital projects. Ensure the C&Q activities associated with various capital projects are completed safely, as per schedule and in compliance with GMP and Quality Requirements.
This role is 100% onsite, 5 days per week.Key Responsibilities:
- Coordinates and Supervises all C&Q activities on their assigned projects.
- Generate C&Q planning documents detailing overall project strategy.
- Develops the master list of project C&Q test documents and activities.
- Generates all C&Q summary reports.
- Ensures the C&Q schedule is developed and maintained.
- Generation of all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Q Summary Report)
- 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)
- 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 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
- Benefit from Independent Solution's ethical principles.
- Pre-interview preparation before attending the interview and help to use STAR technology to answer the questions.
- While placed on client sites you will be an integral part of our team, gaining support and access to the knowledge and experience of our cross-functional Life Science team.
- We offer attractive rates - competitive margins compared to our competitors.
- Payment on time and in full.
- We are recognized as approved suppliers to leading key pharmaceutical and medical device companies.