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Name Of the Company : Horizon
Company Location : Dublin
Country : Ireland
Validation Engineer :
Department: Resourcing
Duties will include but are not limited to the following:
** Conduct business in a manner that will protect human health, safety and the environment by complying with all applicable EHS laws, as well as Global and Technical standards.
** Providing guidance and assistance regarding documentation and requirements for test method validation, process validation, facility, utility and equipment qualification, software validation, raw material and commodity qualification.
** Leading & co-ordinating Site Validation projects as required.
** Planning and assisting in execution of validation and qualification activities.
** Implementation and maintenance of a validation /qualification system that meets applicable internal and external requirements.
** Review of validation / qualification plans, protocols, reports, amendments and other validation / qualification records including Periodic Reviews.
** Provide site training for test method validation, process validation and facility, utility and equipment qualification
** Representing respective SME area during internal and external audits /assessments.
** Assist in identification of process / system improvements across the site, develop and execute plans to address same.
** Provide Quality Engineering support (problem solving, trouble shooting, FMEA, improvement initiative’s) to Manufacturing areas across the site.
** Support all areas in identification and implementation of effective CAPAs.
Skillset Requirements:
** You will have a third level qualification of Science, or Engineering Degree or equivalent with 2 years of experience in regulated industry.
** Demonstrated knowledge of Quality Engineering Tools and Techniques (e.g. Lean / Six Sigma, FMEA).
Project Manager :
** We currently have a vacancy for a Project Manager to join our highly skilled team.
** The successful candiate will manage the entire project captial budget, ensuring that spend targets are on time and within budget.
** The candidate will plan, organize and manage our dedicated Project Management Team that delivers the project on time and on budget.
Job Description :
They will apply advanced and diverse engineering principles (lean/6 sigma) to execute a life science, semi conductor, equipment and process automation facility build and layout with best in class energy efficient processes and utilities.
What we seek from the potential candiate :
** Extensive knowledge of Project Management Techniques, Quality Standards, Environmental Health and Safety and Energy regulatons.
** Excellent organisational, project management, technical, problem solving and communication (written & verbal) skills.
** Demonstrated ability to lead and work with a team influencing them to get the job done, and delivering value-added business results that meet high quality requirements within a tight schedule.
** Demonstrated ability to effectively communicate to a diverse audience, at multiple levels within the company, through various formats.
** In addition, candidates must possess strong interpersonal skills, high level of client focus, and an ability to adapt to a rapidly changing environment.
** Candidate must demonstrate solid technical presentation skills, test protocol writing, organisation, analytical problem solving.
** Must be a proven and experienced leader and have the ability to successfully manager a multitude of projects.
Skills and Abilities:
** Bachelor’s degree in Engineering, Science or related technological / materials field.
** A minimum of 10 years of work experience preferred, with previous experience in the pharmaceutical or biotechnology, process automation areas.
** Project Management (PMBOK) qualification highly desired.
** Demonstrated leadership skills with a tested and proven desire to motivate individuals and management team.
** Excellent Finance acumen.
** Good working knowledgement of Lean Six Sigma (L6S).
How to Apply : Apply through the link given against each job in the official website
http://www.teamhorizon.ie/careers.html
Contact us :
Horizon
34 Upper Baggot St.,
Ballsbridge,
Dublin 4