|Job Ref: 02618||Recruiter: Paul Sinnott|
|Country: Ireland||Location: Dublin|
|Job Category: Pharma Life Science,||Salary Range: €Negotiable|
Equipment / Packaging Validation Engineer (Dublin)
Kppm are currently looking to recruit an Equipment / Packaging Validation Engineer 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.
Reporting to the Engineering Director or assigned line manager. The overall objective of this role is to partake, validate and support a portfolio of project activities on site including new process installations, process modifications and process improvements relating to manufacturing, facility & packaging operations unit. Which could involve involvement in preliminary & detailed design, detailed project plans, regulatory compliance, validation and installation of equipment, progress updates & KPI’s, and the overall support of projects safely, in compliance, on time, in full & within budget with local and external teams.
· Supporting capital projects team for on-site based projects for Oral Solids Dose Manufacturing, Facilities and Packaging operations.
· Perform activities in support of the validation program such as risk assessments and review and assessment of development data in line with recognised standards.
· Is 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.
· Acts as an effective team member in supporting quality disciplines, decisions, and practices.
· Applies sound, systematic problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues.
· Control and compliance of Calibration schedules and associated instruments.
· Develop and maintain existing and future document control practices.
Education & Experience
· Suitable candidates must hold a bachelor’s degree in engineering.
· Minimum 2-5 years’ experience in a Pharmaceutical / Food role as a validation Engineer
· Ability and proven track record in working and managing multiple departmental teams for operational and capital projects.
· Background in Oral Solid dose Manufacturing & Packaging would be advantageous.
· Must possess excellent technical writing ability
· Strong documentation skills
· Have the capacity to work on own initiative and as part of a team.
· Possess strong interpersonal and communication skills
· Must work to the highest engineering standards
· Have strong technical and problem-solving skills
· Experience in cGMP, general manufacturing, facility & packaging systems is advantageous.
· Will require some travel within Europe, depending on project but will be minimal.
This is a staff position and the salary 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 firstname.lastname@example.org
or email email@example.com