Validation Engineer
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 (preferable)
* Knowledge of elements of validation documents (VMP / FAT / SAT / IQ / OQ / PQ etc.) (essential).
* Understanding of production operations, GMP and GLP requirements.
* Demonstrated strong organizational 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 maximizing 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, analyze, interpret technical data, interpret technical procedures, and governmental regulations.
* Be an active learner, developer of self, mentor, coach and develop others.
* Ability to prepare PowerPoint presentations and/or effectively present information and respond to questions, within a group setting.
* Identify with Tcoag’s philosophy of being Best in Class.
Language Skills:
Fluency in English, both written and oral, is a pre-requisite.
The above requirements are not exhaustive and are provided to show the most common tasks and may be amended or updated as required.
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