Job Ref: 02350 Recruiter: Paul Sinnott
Country: Ireland Location: Dublin
Job Category: Process, Pharma Life Science, Salary Range: €Negotiable

Job Description

CQV Engineer (Dublin)

kppm are looking to recruit a CQV Engineer for our client in Dublin. The CQV Engineer shall be responsible for completing Installation Qualification (IQ) and Operational Qualification (OQ) of systems associated with Up-stream Bioreactors and Harvest, Downstream Purification, CIP & SIP, Buffer/Media Prep, Cleanroom HVAC Systems and Clean Utilities on schedule.  The candidate will be a professional, self-motivated, and energetic individual with excellent communication and inter-personal skills.

Duties include but not limited to:

·         Preparation and execution of documents associated with lifecycle of C&Q activities

·         Knowledge of GMP’S, regulatory requirements, equipment commissioning and qualification

·         Co-ordination of the compilation of handover documentation packs (typically material certificates, test certificates, engineering drawings, test procedures, calibration certificates, vendor documents) to demonstrate compliance with the installation / verification processes/procedures on site.

·         Facility (Risk Assessment, DQ/IV/IQ/OQ).

·         Field Walkdowns of systems as part of transfer of ownership of the system from Construction

·         Start-up/Commissioning execution

·         Preparing Change Management and Summary Report Documentation

·         Change Management activities during project lifecycle

·         Summary Report writing- Commissioning Summary reports and IOQ Reports

·         Interfacing with representatives on project team, Construction, Engineering, Automation, Quality and End Users during the different project phases.

·         Vendor /Construction Completion Documentation review

·         Knowledge of GMP’S, regulatory requirements, equipment commissioning and qualification

·         Process Validation Gap Analysis and remediation development

·         Cleaning Validation Gap Analysis remediation development

Training and Experience required

·         Suitable candidates must have a Degree in Science or Engineering (or equivalent experience) with hands on experience of the start-up and on-going operation of process and utility systems or equivalent high spec environment.

·         Candidates must have hands on experience of process control system eg DeltaV or equivalent

·         Experience working in Biopharma roles of engineering, operations, or manufacturing

·         Knowledge of API facility equipment and supporting utility systems

·         Experience of C&Q activities in a large project environment within the pharmaceutical or biotech industries.

·         Knowledge of GMP’S, regulatory requirements, equipment commissioning and qualification

·         Hands on expertise required in one or more of the following areas: Clean Utilities, Fill Line and Formulation Equipment, CIP, HVAC, Process support cleaning equipment. Up-stream Bioreactors and Harvest, Downstream Purification, CIP, SIP, Buffer/Media Prep, Cleanroom HVAC Systems and Clean Utilities, PLC controlled skids.

·         Experience using the ISPE baseline guides including ASTME2500 approach

·         Good written and verbal communication skills

·         High attention to detail.

This is a Contract for Services role and the hourly rate is €negotiable depending on experience.

For further information or to apply please contact: Paul Sinnott Recruitment Consultant at kppm in Dublin on 086 043 8665 or Email paul@kppm.ie

or email paul@kppm.ie

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