PM Group

International project delivery firm for facilities

Lead CSV Engineer

Regulatory & Quality (Life Sciences)Posted on Nov 9

Part-timeCork, IrelandNo salary listedIn-person

About the Job

Requirements

Lead CSV full-lifecycle experience.
CSV experience with process equipment, including filling lines, freeze dryers or lyophilizers, vial washers and tunnels, cappers, autoclaves, parts washers, and storage vessels.
Strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11, and modern CQV CSV practices.
Experience with software and automation validation in a project environment.
A degree-level qualification in Engineering or a science-related area.
Hands-on experience with functional testing of the outlined equipment.
Excellent oral and written communication skills in English.
A high level of customer orientation and understanding.

Responsibilities

Commission and qualify hardware and associated software supporting utility and process equipment, including PLCs, SCADA, and network interfaces.
Prepare commissioning, qualification, and verification protocols for process equipment CSV.
Execute commissioning, installation and operational qualification, and verification for process equipment automation, including clean and black utilities.
Coordinate and review vendor automation packages to achieve streamlined CSV.
Manage people.

Overview

Due to large scale Biotech project wins we now wish to recruit a Lead CSV Engineer to join a highly skilled PM Group team based a client site.

Responsibilities

The following is an example of the day to day activities (however like all large capex projects there will be a good deal of variety).

Commissioning and Qualification of hardware and associated software to support Utility/Process equipment. This includes PLC & SCADA plus interfaces with networks.
Documentation preparation of Commissioning, Qualification and Verification protocols (CQV) for process equipment CSV.
Field execution of Commissioning, Installation & Operational Qualification (IQ/OQ), Verification for process equipment automation, including Clean & black utilities.
Co-ordination/review of Vendor Automation packages to achieve streamlined CSV
People management

Qualifications

We are interested hearing from engineers with

Lead CSV (full lifecycle) experience.
CSV experience of process equipment – Filling lines, Freeze Dryers / Lyos, vial washers & tunnels, cappers, autoclaves, parts washers, storage vessels, etc.
Strong knowledge of regulations (GAMP®5 and 21 CFR Part 11, Annex 11) and modern CQV CSV practices
Experience of working with software/automation validation in a project environment.
A degree level in Engineering, or Science related area
Hands on attitude, specifically functional testing of equipment outlined above.
Excellent oral and written communication skills in English
A high level of customer orientation/understanding

About the Company

PM Group

International project delivery firm for facilities

PM Group is a global project delivery firm focusing on architecture, engineering, construction management, and validation services. It designs and delivers complex facilities for sectors including pharmaceuticals and life sciences, advanced technology and data centers, food and agriculture, and energy. The company provides end-to-end project work—from initial design and engineering through construction management and validation—to ensure facilities meet rigorous industry standards. What sets PM Group apart is its employee-owned structure and its international footprint, with offices across Europe, Asia, and the United States, enabling it to coordinate multidisciplinary teams on large-scale projects worldwide. The company’s goal is to ensure safe, compliant, and efficient delivery of complex facilities for its clients, helping them bring critical infrastructure online on time and within scope.

Company size: 1,001-5,000
Company stage: Not listed
Total funding: Not listed
Headquarters: Machelen, Belgium
Founded: 1973

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