Johnson & Johnson Consumer Inc., a member of Johnson & Johnson’s Family of Companies, is recruiting for a Senior Engineer, Cleaning Validation to be based in Fort Washington, PA. Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products. The Senior Engineer, Cleaning Validation will:
- Lead and execute validation projects at the Fort Washington site. Be responsible for technical support, including cleaning development, validation, and monitoring activities and on-going process optimization.
- Provide technical input for standards, procedures, risk assessments, and regulatory requirements associated with validation practices and execution.
- Provide input into the Product Life Cycle process as it relates to validation requirements.
- Collaborate within the Technical Operations function including Engineering, Liquids, Solids and Packaging Technology Platforms as well as with Quality functions and the Manufacturing sites to establish and continuously improve validation practices, procedures, performance measures, and areas of process improvement.
- Support the site VMP by authoring and/or reviewing sub-volumes, sub-volume supplements and keeping metrics on validation performance measures.
- Present validation execution strategies, deviations, outcomes and metrics to the site VRC and attend or participate in any other VRC meetings as needed.
- Maintain technical training/knowledge in applicable functional area.
- Maintain working knowledge of state of current validation practices across industry.
- Ensures that established validation procedures are being followed in all validation executions.
- Participate in establishing consistent, harmonized, validation processes and procedures across Company Consumer Healthcare OTC businesses and manufacturing sites.
- Authors standard operating procedures.
- Participates in cross-functional teams to lead and execute projects as well as continue improvement in validation practices and procedures.
- Inform direct Management of validation state and issues requiring prioritization.
- Document Validation activities in reports following required procedures and templates.
- Review validation documentation for content and GDP.
- Participate in audits. Support regulatory agency interactions.
- Provide technical support to investigations and resolution of process deviations including complex investigations.
- As applicable, provide supervision and/or guidance to engineers with less experience.
- Bachelor’s of science degree in Chemistry, Pharmacy, Engineering or related technical discipline is required.
- 4+ years of Pharmaceutical Industry related experience is required.
- Experience in cleaning validation is preferred.
- Relevant experience in engineering, technical, and/or operations areas is required.
- Knowledge of cGMPs and Good Documentation Practices is required.
- Working knowledge and application of FDA and ICH regulatory requirements and latest guidance in the development, validation, and manufacture of pharmaceutical and OTC products preferred.
- Ability to collaborate with and influence manufacturing teams regarding prioritization required.
- Knowledge and application of pharmaceutical/OTC cleaning, product and process development; life-cycle management of this class of products including strategies for continuous improvement preferred.
- Ability to direct multiple projects concurrently; to periodically assess and re-direct resources as indicated in a dynamic environment preferred.
- Ability to provide technical leadership in problem-solving and decision-making; to collaborate with and influence business partner leaders with a focus on data, science, and technology preferred.
- Oral and written communication and presentation skills are required.
- Six Sigma Green Belt certification is preferred.
- This position is based in Fort Washington, PA and may require up to 10% travel based on business needs.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Primary LocationNorth America-United States-Pennsylvania-Fort WashingtonOrganizationJ & J Consumer Inc. (6101)Job FunctionEngineering (Generalist)
Internal ID: 3621170614