- 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.
- This will include 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.
- 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 packaging systems and serialisation is advantageous.
- Will require some travel within Europe, depending on project but will be minimal.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100