Ref No: AM17518
County Cork, Republic of Ireland
Packaging Validation Engineer - County Cork.
This role has a targetted focus on supporting Packaging day to day operations & projects in a dynamic environment. Flexibility & agility required to support other validation workstreams as required to meet the business needs. Ability to integrate risk-based validation strategies to site projects and work towards a positive and energised team dynamic and environment.
Core duties include:
Responsible for aiding the development of risk-based validation strategies for the implementation of validation projects and CAPEX programs.
Execution of packaging validation activities in alignment with planning & packaging functions.
Operational support for product launches, change assessments, deviations, CAPA's, etc.
Execution of internal product transfers between lines and vial inspection systems.
Qualification of new components and suppliers.
Ensure the quality & governance of completed work.
Foster validation team and cross-functional working relationships to deliver site mandated programs of activities on schedule and to high performance standards.
Identify and drive functional continuous improvement initiatives to achieve compliant and lean sustainable solutions.
Prepare protocols, reports and data tables
Investigate and troubleshoot problems which occur and determine solutions
Participate in cross-functional governances with key stakeholders, on cross-functional project teams & functional / site MDI boards.
Presents validations in respective SME areas at internal and external audits.
Interested applicants should have:
In-depth understanding and application of validation principles, concepts, practices, and standards including the application of ASTM E2500.
Extensive working knowledge of equipment and systems- specifically primary and secondary packaging, serialisation and aggregation systems.
Knowledge of industry best practices.
Excellent verbal, technical writing, and interpersonal communication skills are required.
Operational Excellence (Lean and Continuous Improvement) mindset.
Proficient in Microsoft Office applications.
Ability to engage and manage multiple stakeholders to achieve business objectives.
Learning agility across systems, equipment and new technologies.
A good level of relevant experience and minimum Bachelor’s degree in science or a related field.