Product and Process Engineer

About the role

The Product and Process Engineer is part of a team responsible for maintaining comprehensive product and process knowledge at the site. It supports validated manufacturing through collaboration with cross-functional groups, execution of process and cleaning validations, ongoing risk assessments, and alignment on technical changes to ensure product quality and regulatory compliance.

Role Responsibilities

• 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.

Basic Qualifications

Preferred Qualifications

Location

Lincoln, Nebraska. This role is not a remote role.

Benefits and Compensation

Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program. This includes a generous 401(k) plan, tuition reimbursement and time off programs including 6 months paid parental leave. On day one, you are eligible for benefits, including our healthcare programs where the company pays for the majority of your medical coverage for you and your family. We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive / recognition programs as part of the offering.

Equal Opportunity Employer

Haleon is an Equal Opportunity Employer and, in the US, we adhere to affirmative action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity or expression, age, disability, genetic information, military service, covered or protected veteran status or any other federal, state or local protected class.

Accommodation Requests

If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please contact us by sending an email to HR.AmericasSC-CS@haleon.com . Please include the following in your email :

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