GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client's needs. We are currently hiring for a Validation Engineer for our Sligo based client.
Key Responsibilities:
* Laboratory Validation Engineer: The QC Pharma Department is responsible for the qualification/validation of laboratory equipment, systems and processes utilized for routine operation at Laboratories. The Department is also responsible for the revalidation of critical roles of the Validation Engineer to ensure customer satisfaction is delivered with each revalidation, validation, and project work. All validation activity is to be performed in line with Global Standards, FDA, HPRA, and other MPH regulatory requirements. This schedule compliance will be achieved by actively engaging with senior management and the impacted BU's and ensuring all projects can be managed and prioritized as required.
* Major Duties and Responsibilities:
o Oversee, coordinate, guide, and implement the site validation master under prospective, concurrent, and retrospective validation studies in a timely manner, with the relevant engineers.
o Actively work on validation projects, being the departmental point person and completing all associated project documentation in line with current corporate and regulatory expectations.
o Participate in risk assessment processes for all business units & participate in design review processes for all business units.
o Track and generate weekly metrics (GTW QMS, EHS, Compliance Wire, etc.).
o Facilitate the PQR review process/Regulatory Review Process and Laboratory Equipment Review Process as per the current rotas.
o Keep abreast of current and changing regulatory guidance for the relevant areas of validation that applies.
o Support and comply with internal EHS requirements, procedures, and policies.
o Provide support for audit preparation, direct audit interaction and involvement in audit response.
Education & Experience:
* Bachelor's degree required in a science-based or engineering discipline.
* Experience in a Pharmaceutical company.
* Excellent project management skills.
* Proficient in the use of Microsoft Office suite of programs.
* Critical thinking and problem-solving skills.
* Ability to articulate clearly when dealing with internal and external bodies.
* Excellent conflict handling skills.
* Expertise in the relevant subject matter areas - example Equipment, Facility, Aseptics, Process, CPV, CSV, Cleaning.
We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment. If you are a motivated Validation Engineer seeking an exciting challenge in the biopharmaceutical industry, we encourage you to apply.
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