|Job Ref: 02139||Recruiter: Paul Sinnott|
|Country: Ireland||Location: Dublin|
|Job Category: Process, Pharma Life Science,||Salary Range: €Negotiable|
Validation Engineer s – Equipment – (Dublin) – All Levels
Kppm are currently looking to recruit a number of Validation Engineer (s) for our client a global pharmaceutical leader with 50+ years providing medicine to people throughout the globe for various medical conditions including: Cardiovascular, Diabetes, Gastroenterology, Immunology, Infectious Diseases, Oncology, Respiratory, Women Wellness helping fight disease while focused on wellness. Currently have 635 products, employing 35,000 people with sales of $11.11 billion globally.
You will be responsible for maintaining all associated equipment validation documentation and work along beside current validation & engineering teams.
Education and Experience
· Suitable candidates must have a 3rd Level Degree in Science or Engineering qualification.
· Candidates required at various levels including 2 – 5 year’s experience & 5 – 10+ year’s experience.
· A good working knowledge of the GMP regulations.
· Excellent report writing skills.
· A strong knowledge of validation procedures.
· Good communication and PC skills.
· Perform activities in support of the validation program such as risk assessments and review and assessment of development data in line with recognised standards.
· Responsible for development, approvals control, execution and closure of the Validation Project plan for all tests.
· Responsible for retrospective reviews and update of existing validation system or documents.
· Liaise with Manufacturing / Packaging/ Facilities Engineering and end users on the completion of risk assessment for any product line extensions, process improvements or automation projects.
· Verifies that validation studies once complete have been adequately recorded, documented and carried out, in accordance with the approved Validation Plan and Protocols.
· Provides information on relevant regulations and internal process validation policy with regards to equipment/process validations and qualifications.
· Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation / Engineering Team.
· Provides guidance in closing out noncompliance and deviations in relation to Validations.
· Provides assistance and ensures the preparation of validation protocols, process design specifications and associated documentation for equipment and systems.
· Participates in project teams and assists in determining project schedules and the relevance of appropriate levels of validation
· Works with teams and other departments across the plant to ensure project adherence.
· Applies sound, systematic problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues relating to validation.
· Develop and maintain existing and future document control practices.
· To participate, lead, assist, investigate or execute Capital projects to site as required.
· To ensure that good GMP standards are maintained at all times.
· Support the implementation of the Operational Excellence Program on the site by identifying and implementing improvements.
· To adhere to all company and legislative health, safety and environmental requirements.
· Any other duties as assigned by the Facilities & Projects Manager, Engineering Director
This is a Contract for Services role and hourly rate is €negotiable depending on experience.
For further information or to apply please contact: Paul Sinnott Recruitment Consultant at kppm in Dublin on 086 043 8665 or Email email@example.com
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