On behalf of our client, a global medical devices company, we are currently recruiting for a Validation Engineer. This is a permanent, full-site position site based in North Wicklow/South Dublin.
Reports to
Maintenance, Engineering and Validation Manager
Essential responsibilities
- Compilation and execution of validation protocols
- Compilation of validation summary reports
- Collection, test, measurement, data entry, data analysis of samples
- Software Validation
- Statistical Analysis (in particular data interpretation, sample sizes)
- Validation documentation review
- Be an active contributor to Calibration activities on-site
Qualifications/Experience required:
- Minimum 3 years industrial experience in a facility manufacturing in pharmaceutical environment, vitro diagnostic products or equivalent
- Educated to BSc. Level in a science or engineering related discipline or equivalent (preferrable)
- Knowledge of elements of validation documents (VMP / FAT / SAT / IQ / OQ / PQ etc.) (essential).
- Understanding of production operations, GMP and GLP requirements.
- Demonstrated strong organisational skills from both administrative and hands on standpoints
- Demonstrate a high level of care and attention to all aspects of the role and show a desire to achieve excellence through own initiative
- Proven to be a team player, capable of working within multiple areas while maximising performance
Familiarity in the use of the following equipment, instrumentation and software would be advantageous:
- Incubators, Fridges, Freezers, Cold Rooms.
- Filling, Stoppering, Capping, Labelling, Packing manufacturing lines (fully automated, semi-automatic or manual)
- Freeze Drying processing equipment
- Validation of Computerized Systems (FDA regulation)
- Microsoft office (Word, Excel, PowerPoint etc.)
- Statistical Software
Skills and Behaviours
- The successful applicant will have excellent communication skills, (both written and verbal), excellent interpersonal and presentation skills and be team focused.
- The successful applicant’s professional characteristics will include attention to detail, initiative, ingenuity, creativity, resourcefulness, flexibility and perseverance.
- The successful applicant will work with a sense of urgency, be able to prioritize appropriately, have excellent organizational skills and have the ability to be impartial and objective.
· The successful applicant will have a Continuous Improvement mindset, with demonstrated achievements from previous roles
- Have a willingness and ability to collaborate with and influence other groups, in a positive, team‑based environment
- Have excellent problem solving and troubleshooting skills
· Ability to read, analyse, interpret technical data, interpret technical procedures, and governmental regulations.
· Be an active learner, developer of self, mentor coach and develop others
· Ability to prepare Power point presentations and/or effectively present information and respond to questions, within a group setting
Language Skills:
Fluency in English, both written and oral, is a pre-requisite.
For a full Job Spec and to apply for this role please call Linda on +353 1 2784671 or e-mail [email protected]
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671
