Job Ref: 02139 Recruiter: Paul Sinnott
Country: Ireland Location: Dublin
Job Category: Process, Pharma Life Science, Salary Range: €Negotiable

Job Description

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.

Duties

·         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 paul@kppm.ie

or email paul@kppm.ie

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