Job Details: Clean Utilities CQV Specialist


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Clean Utilities CQV Specialist
CLEAN UTILITIES CQV SPECIALIST

ROLE

The successful applicant will work as part of a multi-functional
Utilities Team responsible for Qualification, Validation Maintenance,
Revalidation and periodic review activities associated with GMP
Critical Utility Equipment and Systems at our clients state of the art
Biotech Facility in North Dublin

RESPONSIBILITIES:

* Develop, review and execute GMP critical utility Performance
Qualification (PQ) protocols and PQ reports for GMP Critical systems
e.g. HVAC, RO/PW/WFI, Clean Steam, Clean Compressed Gasses, walk in
cold storage.

* Preparation and approval of Utilities Validation SOPs

* Preparation and approval of Validation test equipment SOP&#**Apply
on the website**;s

* Generation of qualification risk assessment/testing matrix for
qualification protocols and supporting documents in line with User
Requirements/Equipment Specifications/ MSD and cGMP compliance.

* Management of Validation Test equipment with support from site
maintenance management team. (Calibration/System Maintenance and
Calibration Event handling)

* Qualification of Validation test equipment.

* Equipment/System assessments for &#**Apply on the website**;Computer
System Qualification&#**Apply on the website**; requirements and
&#**Apply on the website**;Execution of Electronic Records and
Electronic Signatures&#**Apply on the website**; requirements.

* Identify, document and track validation events

* Full oversite of all personnel and contractors participating or
executing PQ activities, ensuring all team members are trained and
follow the relevant site procedures.

* Responsible for ensuring documentation being leveraged for PQ
testing from project commissioning phase/IQ/OQ are referenced as per
associated qualification, referencing procedures.

* Validation tasks/actions associated with quality system change
controls and investigations.

* Development/Generation of Utilities Validation Master Plan.

* Periodic review and revalidation assessment.

REQUIREMENTS

* Extensive cGMP experience in Commissioning Qualification &
Validation, ideally covering GMP Critical Utilities Equipment
Engineering.

* Good understanding of Instrumentation/Calibration, Utilities
Equipment incl. HVAC, WFI/RO/PW, Clean Steam Gases, Refrigeration
Systems

* Understanding of Maintenance/Calibration requirements of such
systems is also a requirement.

* BSc or MSc/MEng Degree in Engineering or equivalent.

* Excellent verbal and written communication skills.

* 5 years Plus Engineering CQV experience.

* In depth knowledge and experience with validation test
equipment/systems.

* Have capability and experience to manage Vendors and Contractors
supporting PQ activities.

* Ability to work independently and as part of a team in a cross
functional collaborative environment CLEAN UTILITIES CQV SPECIALIST

ROLE

The successful applicant will work as part of a multi-functional
Utilities Team responsible for Qualification, Validation Maintenance,
Revalidation and periodic review activities associated with GMP
Critical Utility Equipment and Systems at our clients state of the art
Biotech Facility in North Dublin

RESPONSIBILITIES:

* Develop, review and execute GMP critical utility Performance
Qualification (PQ) protocols and PQ reports for GMP Critical systems
e.g. HVAC, RO/PW/WFI, Clean Steam, Clean Compressed Gasses, walk in
cold storage.

* Preparation and approval of Utilities Validation SOPs

* Preparation and approval of Validation test equipment SOP&#**Apply
on the website**;s

* Generation of qualification risk assessment/testing matrix for
qualification protocols and supporting documents in line with User
Requirements/Equipment Specifications/ MSD and cGMP compliance.

* Management of Validation Test equipment with support from site
maintenance management team. (Calibration/System Maintenance and
Calibration Event handling)

* Qualification of Validation test equipment.

* Equipment/System assessments for &#**Apply on the website**;Computer
System Qualification&#**Apply on the website**; requirements and
&#**Apply on the website**;Execution of Electronic Records and
Electronic Signatures&#**Apply on the website**; requirements.

* Identify, document and track validation events

* Full oversite of all personnel and contractors participating or
executing PQ activities, ensuring all team members are trained and
follow the relevant site procedures.

* Responsible for ensuring documentation being leveraged for PQ
testing from project commissioning phase/IQ/OQ are referenced as per
associated qualification, referencing procedures.

* Validation tasks/actions associated with quality system change
controls and investigations.

* Development/Generation of Utilities Validation Master Plan.

* Periodic review and revalidation assessment.

REQUIREMENTS

* Extensive cGMP experience in Commissioning Qualification &
Validation, ideally covering GMP Critical Utilities Equipment
Engineering.

* Good understanding of Instrumentation/Calibration, Utilities
Equipment incl. HVAC, WFI/RO/PW, Clean Steam Gases, Refrigeration
Systems

* Understanding of Maintenance/Calibration requirements of such
systems is also a requirement.

* BSc or MSc/MEng Degree in Engineering or equivalent.

* Excellent verbal and written communication skills.

* 5 years Plus Engineering CQV experience.

* In depth knowledge and experience with validation test
equipment/systems.

* Have capability and experience to manage Vendors and Contractors
supporting PQ activities.

* Ability to work independently and as part of a team in a cross
functional collaborative environment

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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