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 cGMP 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.
Why PM Group?
As an employee-owned company, we are inclusive, committed and driven. Corporate
Responsibility and Sustainability are the heart of our new 2025 business strategy.
Please visit our website to read more in our Corporate Responsibility & Health and
Safety Report 2020.
Inclusion and Diversity are core to our culture and values. Wherever we work, we
commit to a culture of mutual respect and belonging by building a truly inclusive
workplace rich in diverse people, talents and ideas. Valuing the contributions of all
our people and respecting individual differences will sustain our growth into the
future.
PM Group is committed to ensuring our hiring process is fair and accessible to all
and will provide candidates with disabilities with reasonable accommodations
required to participate in the recruitment process. If you require any assistance in this
regard, please let us know.
#LI-JF1