Commissioning and Qualification Management on a Biotech plant?
This is a contract role based in Dun Laoghaire, Dublin.
If you have the relevant experience, please forward your CV to **Apply
on the website** for review or call *-**Apply
on the website** to discuss in confidence.
CQV ENGINEER - BIOTECH PLANT - DUBLIN
JOB DESCRIPTION
Our client is a leading international Biotechnology company with a
state of the art aseptic manufacturing facility in Dun Laoighaire,
South Dublin.
The plant is one of the most dynamic in Ireland and is currently
undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into
Ireland&# *;s leading aseptic manufacturing
plant.
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.
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)
REQUIREMENTS
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
PACKAGE
Contract role
Hourly Rate € * - € *
per hour
Minimum * month contract
Onsite expectations: 5 days per week
We need : English (Good)
Type: Permanent
Payment: EUR 55 - 65 Per Hour
Category: Construction
