Validation Engineer – Co. Dublin
Role Summary:
- A new opportunity has arisen for a Equipment / Packaging Validation Engineer at our client’s busy pharmaceutical facility in Co. Dublin.
- 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.
Core Duties and Responsibilities:
- 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.
Qualifications and Experience:
- A bachelor’s degree in engineering.
- Minimum 2-5 years’ experience in a Pharmaceutical / Food role as a Validation Engineer
- 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 serialization is advantageous.
- Will require some travel within Europe, depending on project but will be minimal.
To Apply:
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
recruitment@prochem.ie
Please note, we do not require agency assistance with this role.
