CQV Engineer
Multiple LTD Contractor Roles Across Different Project Areas
Location:
Dublin
Contract Type:
LTD Contract
I am partnering with a leading pharmaceutical client who is expanding their CQV team and now seeking several experienced Contractors across Clean Utilities, Formulation and Component Prep and DPSL equipment. These roles are onsite and ideal for candidates with strong sterile drug product CQV backgrounds who enjoy delivering high quality commissioning, qualification and validation in a fast moving project environment.
Clean Utilities C&Q Engineer
Responsibilities
* Develop and execute CQV documentation for Clean Utilities
* Support project deliverables for safety, CQV schedule and documentation quality
* Ensure GMP and utility systems comply with EU and FDA standards
* Manage deviations for assigned utilities and equipment
* Identify and mitigate qualification risks
* Execute FAT testing and integrate results into qualification activities
* Complete all mandatory site training
Requirements
* Experience with high purity water systems such as Purified Water, WFI, Clean Steam and High Purity Gases
* Proven CQV lifecycle experience from design to handover
* Strong documentation and planning skills
* Excellent communication and teamwork
* Experience with digital validation platforms desirable
* Degree in science or engineering plus 5 or more years CQV experience
CQV Engineer Formulation and Component Prep
Responsibilities
* Develop and execute CQV documentation for formulation and component prep equipment
* Deliver project milestones across safety, schedule and documentation quality
* Ensure GMP and non GMP equipment meet regulatory and commissioning standards
* Manage deviations and perform risk assessments
* Execute FAT activities and incorporate results into qualification
* Meet all training and compliance expectations
Requirements
* Experience with sterile drug product equipment
* Experience with Single Use Mixers, TCUs, Utility Panels, Filtration Systems, Autoclaves, Parts Washers, Blenders and Jet Mills
* Strong document preparation and execution skills
* Excellent communicator with strong cross functional collaboration
* Degree in science or engineering plus 5 or more years CQV experience
CQV Engineer DPSL
Responsibilities
* Develop and execute CQV documentation for benchtop, mobile and analytical equipment including PAT tools, incubators, BSCs and TCUs
* Deliver on safety, schedule and documentation quality
* Ensure GMP equipment meets internal and regulatory standards
* Manage deviations and support risk mitigation
* Execute FAT testing and integrate learnings into qualification
* Complete required training in line with site metrics
Requirements
* Experience commissioning and qualifying small scale sterile equipment
* Strong CQV lifecycle experience
* Excellent documentation and planning capability
* Experience with ValGenesis or Kneat desirable
* Degree in science or engineering plus 3 to 5 years pharmaceutical CQV experience
Next Steps
Should this position be of interest to you please submit your CV to Jessica using the apply button.
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