Haleon is looking to hire a Product & Process Engineer to be the principal point of contact for all aspects of current and previous knowledge on product(s), performance and end-to-end process, including critical quality attributes (CQAs) and critical process parameters (CPPs). The role is accountable at site level for maintaining this knowledge and sharing it on site and globally as appropriate.
Requirements
- Track record of improving products, processes and troubleshooting, execution of technical activities including trials and validation activities
- Experienced in technology transfer, with an understanding of the product development process and manufacturing equipment
- Able to evaluate potential innovative technology areas relevant to product
- Thorough knowledge of GMP and EHS requirements
- Demonstrated in-depth knowledge of Quality by Design and risk management approaches
- IT Skills: MS Office, SAP, Power BI
Responsibilities
- 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.
Other
- BS degree in Chemistry, Engineering, or related area
- Minimum of 3 years in Manufacturing Science, Product Development, or Technical Operations role
- Demonstrates ability to contribute to and effectively influence matrix teams, colleagues in other functions and senior stakeholders
- Demonstrated ability to mentor operational staff and support functions
- Project management skills
