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Validation Engineer, Carlow

Ireland, Carlow, Carlow
Last update 2024-07-24
Expires 2024-08-24
ID #2213229947
Free
Validation Engineer, Carlow
Ireland, Carlow, Carlow,
Modified June 29, 2024

Description

Overview PM Group is an employee owned, international project delivery firm with a team of 3,700+ people.

We are world leaders in the pharma, food, medtech and mission critical sectors.

From our network of offices in Europe, Asia and the US, we work with the world's leading organisations.

We are focused on growing a sustainable business centred around our people, our clients and trade partners.

The PM Group now has an opportunity for a Validation Engineer (with isolator experience), to work on-site with a pharmaceutical client based in Carlow.

Responsibilities To lead and/or support validation projects and activities on site, as directed and as appropriate.

To prepare validation plans in line with the strategic goals of the client and to manage timely and compliant delivery of the plan.

Commissioning and validation of various new technologies and new equipment.

To develop and execute Commissioning & Qualification lifecycle protocols as per the specific project requirements.

Leading and supporting SATs.

Supporting and representing the technical quality team in meetings, visits, troubleshooting exercises, and audits.

Ensuring manufacturing equipment is qualified in line with production schedule requirements.

Developing and writing validation procedures according to c GMP and regulatory requirements.

Generating and executing validation documentation.

Providing continuous improvement for existing validation procedures.

Data collation and analysis via sophisticated computer software.

Sterilisation – Autoclaves, SIP of vessels; Cleaning – Parts Washer and CIP of vessels; Isolator (Filling, Sterility & Material Transfer isolators) – HVAC, VHP, E-Beam and Depyrogenation systems; Controlled Temperature Units (CTU) – Temperature/Humidity Mapping; Filter Validation.

Qualifications Science / Engineering Degree and 5 years plus relevant experience including with pharmaceutical isolator experience.

Experience in executing multiple projects and participating on cross-functional project teams Organizational skills for concurrent execution of multiple equipment/instrument, facility and utility qualifications and projects Excellent organisation, communication, computer, & presentation skills.

Excellent initiative, decision-making and be able to work in a core team environment attaining resolutions.

Performance and Results driven.

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Monthly
Occupation: Validation engineer

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