Job Details: CQV CSV Engineer


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
CQV CSV Engineer
CQV CSV Engineer

Purpose

Support the construction management and qualification of an ongoing
project and additional expansion.

The project involves installation, commissioning and qualification of
facilities, utilities, equipment and control systems associated with
the expansion at the ATMP facility. It will involve tie ins to
existing installation (electrical/CO2) IOQ of production equipment,
centrifuges, CO2 Incubators, Isolators, Microscopes etc. for the
manufacture a regenerative cell therapy product. There will be
extensive piping, building services (HVAC), new utilities and
extensions to existing utilities, together with an upgrade to the
control system.

Duties

Develop and write C&Q documents following established standards

Performs and assists with execution of commissioning associated with
the start-up, and qualification protocols.

Ensures projects are managed in conjunction with all regulatory
requirements (Health & Safety, cGMP, construction, environmental etc.)

Performs walk-down and verification of system drawings (i.e., P&IDs,
as-builts, etc.) Management of development and execution of IQ and OQ
activities, Summary Reports, Risk Assessments, Specifications (URS),
FATs / SATs.

Review/approve execution of the commission and qualification plans.

Review of all design deliverables including drawings, datasheets,
specifications and engineering lists.

Point person for review for all associated vendor packages.

Liaise with Engineers in relation to construction readiness and a
schedule for systems/equipment within areas of responsibility.

Minimum Qualifications And Experience

8+ years&#**Apply on the website**; experience working in a similar
role within an ATMP, Bio-Pharmaceutical or pharmaceutical environment
and has successfully completed a number of start-ups.

Experience of Commissioning and Qualification in a project
environment.

Hands on attitude, specifically functional testing of equipment and
systems outlined above.

Bachelor&#**Apply on the website**;s Degree Engineering (or
equivalent)

Experience of Thermal Mapping.

Experience of implementing systems in accordance with **Apply on the
website**CFR Part **Apply on the website** regulations i.e. Electronic
Sigs & Electronic Records which also leads on to data Integrity &
Audit Trail review.

Experience with Data Management Systems, OSI PI, OPC, Historians.

Knowledge of requirements for design, installation, commissioning,
qualification of pharmaceutical Facilities, utilities and equipment.

Specific knowledge of cell therapy process.

Very strong problem-solving skills, ideally using formal tools e.g.
FMEA.

Strong understanding of pharmaceutical industry regulatory
requirements.

Highly motivated with ability to work effectively with as part of a
team or independently.

Knowledge of recent regulations (ICH, ASTM, FDA, ISPE) and modern CQV
practices CQV CSV Engineer

Purpose

Support the construction management and qualification of an ongoing
project and additional expansion.

The project involves installation, commissioning and qualification of
facilities, utilities, equipment and control systems associated with
the expansion at the ATMP facility. It will involve tie ins to
existing installation (electrical/CO2) IOQ of production equipment,
centrifuges, CO2 Incubators, Isolators, Microscopes etc. for the
manufacture a regenerative cell therapy product. There will be
extensive piping, building services (HVAC), new utilities and
extensions to existing utilities, together with an upgrade to the
control system.

Duties

Develop and write C&Q documents following established standards

Performs and assists with execution of commissioning associated with
the start-up, and qualification protocols.

Ensures projects are managed in conjunction with all regulatory
requirements (Health & Safety, cGMP, construction, environmental etc.)

Performs walk-down and verification of system drawings (i.e., P&IDs,
as-builts, etc.) Management of development and execution of IQ and OQ
activities, Summary Reports, Risk Assessments, Specifications (URS),
FATs / SATs.

Review/approve execution of the commission and qualification plans.

Review of all design deliverables including drawings, datasheets,
specifications and engineering lists.

Point person for review for all associated vendor packages.

Liaise with Engineers in relation to construction readiness and a
schedule for systems/equipment within areas of responsibility.

Minimum Qualifications And Experience

8+ years&#**Apply on the website**; experience working in a similar
role within an ATMP, Bio-Pharmaceutical or pharmaceutical environment
and has successfully completed a number of start-ups.

Experience of Commissioning and Qualification in a project
environment.

Hands on attitude, specifically functional testing of equipment and
systems outlined above.

Bachelor&#**Apply on the website**;s Degree Engineering (or
equivalent)

Experience of Thermal Mapping.

Experience of implementing systems in accordance with **Apply on the
website**CFR Part **Apply on the website** regulations i.e. Electronic
Sigs & Electronic Records which also leads on to data Integrity &
Audit Trail review.

Experience with Data Management Systems, OSI PI, OPC, Historians.

Knowledge of requirements for design, installation, commissioning,
qualification of pharmaceutical Facilities, utilities and equipment.

Specific knowledge of cell therapy process.

Very strong problem-solving skills, ideally using formal tools e.g.
FMEA.

Strong understanding of pharmaceutical industry regulatory
requirements.

Highly motivated with ability to work effectively with as part of a
team or independently.

Knowledge of recent regulations (ICH, ASTM, FDA, ISPE) and modern CQV
practices

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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