Product and Validation Lead

Key Responsibilities
- Manages, motivates and encourage a team of Product and Process Engineers to support Product Lifecycle Management of products manufactured on site.
- Accountable for oversight, management, and delivery of all Validation Lifecycle components. Provides guidance and support on validation, in terms of standards, approach and execution. As the validation expert, supports internal and external audits ensuring successful outcome.
- Understands and ensures compliance to evolving expectations of: Equipment and Facility C&Q, Process/Packaging validation, Cleaning validation, Continued Process validation (CPV), Analytical Method validation, and Computer System validation
- Collaborates across Engineering, Quality and Technical departments to ensure validation activities are completed on time and validation SOPs are compliant to Haleon Quality standards and GMP.
- Ensures that the site can demonstrate system compliance to a regulatory auditor, (e.g., TGA, NPRA, FDA)
- Maintains and ensures site validation master plan (SVMP) adherence
- Identify quality risks in validation projects and supports risk mitigation. Facilitates validation Risk assessment and deviation investigation.
- As the site cleaning SME, maintains the site cleaning lifecycle process by assessing impact of new products, processes, or changes against the existing site cleaning matrix. Coaches and develops the Technical team to ensure that cleaning validation execution demonstrates that the process produces the expected results in a reproducible manner, and that proper monitoring is in place to ensure the processes remain in a validated state of control

Qualifications & Skills:
BS degree in engineering, industrial pharmacy, chemistry, or other appropriate scientific or pharmaceutical discipline.

Minimum of 5 years of demonstrated experience in Technical role, preferably with strong experience in cleaning validation
- Related experience in production operations, Quality, Lab analytical preferably
- Role supports decision making associated with product quality
- Role has supervisory responsibilities
- Good command of English
- Understanding of the industry, regulatory and organization quality standards attention to detail

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Haleon is an Equal Opportunity Employer. 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/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.

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