
Product and Process Engineer
- Dungarvan, Co Waterford
- Permanent
- Full-time
- Recognized as the principal point of contact for all aspects of current and previous knowledge on the product(s), performance and end to end process, including critical quality attributes (CQAs) and critical process parameters (CPPs). Accountable at site level for maintaining this knowledge and sharing on site and globally as appropriate.
- Liaise with Regional and Global Technical, as well as other site functions such as QA, QC, Engineering, and Operations to ensure that proper controls are established and maintained for products to be manufactured in a validated state of control.
- Implement and maintain continued process verification (CPV), as appropriate, for determined products and processes on site. Incorporate data trending and statistical analysis to verify that processes remain in a validated state of control, and to proactively identify trends which may provide risk to the product.
- Maintains and periodically reviews product control strategies (PCS) and technical risk assessments (TRA) as required.
- Provide all necessary information to develop and execute process validation, working across multiple functions to collect the appropriate inputs for validation protocols and authoring validation reports. Validates the manufacturing and packaging process parameters necessary to assure product quality, and incorporates this into the PCS.
- Lead or contributes to, as required, change controls impacting products or manufacturing processes. Ensure alignment of timelines and activities required for technical changes, product transfers, major deviations, and investigations.
- Performs risk assessments on cleaning processes, as required for new products, processes, or materials introduced to the site, and ensuring appropriate validation is implemented. This includes HBEL, MACO, residual solvent calculations, and other assessments to support cleaning validation needs. Develops and works with Operations to execute protocols for cleaning validation, and issues validation reports.
- Leaving Certificate plus Third Level qualification or extensive period in similar role
- A number of years of experience in a logistics planning role (such as Inventory Management, Procurement, Supply Planning, Site Scheduling & Project Management). with enterprise level FMCG or pharma firm.
- Advance capability and experience using Microsoft Excel.
- Proven capability and experience using the SAP MERP platform.
- Ability to communicate effectively and productively with suppliers.
- An ability to engage productively with key stakeholders in function.
- An attention to detail mindset.