Overview:
We wish to appoint a CQV Engineer for Co. Kildare, Ireland. The successful candidate will have a proven track record of working with multi-discipline Engineering, Project Management and GMP Regulations.
Who We Are:
No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.
We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.
By joining our team, you will have the opportunity to make a meaningful impact in the pharmaceutical industry while advancing your career.
Scope and Responsibilities:
- Perform Commissioning and Qualification/Validation for Project in compliance with GMP regulations, specification requirements.
- Protocol generation or review for the assigned areas and summary reports for initial and subsequent re qualification programs related to E/F/U systems.
- Review vendor or construction turnover document.
- Participate/lead system walkdowns to assure compliance with design.
- Support or direct execution of full Commissioning and Qualifying project lifecycle, including URS, Design Verification, FAT, SAT, DQ, IQ, OQ and PQ etc.
- Trouble shooting equipment with cross functional teams.
- Support or lead summary report writing.
- Support the review and revision of design document.
- Support the handover of assigned system.
- Support the management of project schedule.
- Compliant to quality and safety requirements.
Qualifications:
- Bachelor of Science, Engineering, or related scientific degree.
- Experience in Pharma Industry is preferred.
- Min. 5 years of experience in Commissioning and Qualifying project is required.
- Knowledge of cGMP regulations and industry standards such as ISPE GAMP, and FDA guidance documents.
- Ability to work in a fast-paced environment.
- Time management skill and attention to detail.
- Strong interpersonal and communication skills.