Sr. Process Engineer - 2307013385W

　　DESCRIPTION/RESPONSIBILITIES:DescriptionKenvue is currently recruiting for:Sr Process Engineer

　　This position reports into the Senior Manager MS and T in Fort Washington, PA.

　　As a member of the North America team in the Manufacturing Sciences & Technology (MS&T) department, this position provides technical support primarily to commercial liquid, and / or semi-solid pharmaceutical products, new products in development, and technology transfer activities.

　　What You Will DoThe Senior Process Engineer will engage in formulation and process development activities, characterization, process performance qualification, and continued process verification. Work is primarily focused on support of the Fort Washington Manufacturing facility for our Self Care OTC franchise.

　　The incumbent will ensure quality and compliance in all cGMP related activities, maintain all required training for the role, and follow standard operating procedures to complete the required work. The individual possesses a deep understanding of the principles of manufacturing processes, material interactions and has a demonstrated passion for innovation and continuous improvement. Works with minimal direction. Influences internal and external cross-functional partners and stakeholders at multiple levels in the organization (such as Quality, R&D, and Supply Chain). Will maintain multiple projects at once.

　　Key Responsibilities:* Design and complete experiments/deliverables at small and large/commercial scale to support project objectives that supports base business. Project tasks may include sample collection, in process testing, sample management, data analysis, etc.* Champions and leads technical aspects for manufacturing process improvements through data analysis identification of critical process parameters, the proposal of alternate process modifications, assistance in conducting DOE to determine the best processes, assistance in conducting scale-up activities including pilot-scale and validation as required.* Oversees, prepares, reviews or approves technical memos or reports by analyzing data, developing conclusions and recommendations based on sound scientific principles.* Effectively leads, communicates, and partners with cross-functional peer group and management. Lead and/or participate as a technical team member or technical representative on cross functional teams.* Commercial business support including: change control deliverables/documentation, investigations, CAPAs, and APR data collection, analysis and review/approval. Write and/or approve standard operating procedures or provide input to SOPs, policies, and standards. Is a trusted voice for and provides technical advice on SOPs, policies, and procedures.* Leads technical aspects for solving critical supply issues, provide technical troubleshooting and recommendations using knowledge, experience, data analysis, and problem-solving tools to address sophisticated technical problems that may have a direct impact on commercial product quality or supply. May also prepare, review, or approve regulatory documents (e.g. related to NDA, ANDA, or SNDA).

　　QualificationsWhat We Are Looking ForRequired Qualifications* Bachelor's of Science degree or equivalent in Engineering, Chemistry, Pharmacy or a related technical field required.* 4 years of pharmaceutical manufacturing related experience is required. Experience with liquid oral dose manufacturing is required.Knowledge of GMPs, ICH, CFR is required.* Strong knowledge and experience in processes such as scale-up, process validation, product/process technical transfer, or product life cycle management/continued process verification is required.* Solid understanding of scientific principles for liquid/semi-solid formulation development (i.e., solution, suspension, semi-solid) and/or other formulation development in support of scale-up and technology transfer is required.* Strong p ocess knowledge in liquid manufacturing such as mixing and filling operations is required.* Knowledge and understanding of sampling requirements and the collection and evaluation of data, from the process design stage through commercial production is required. Office deskwork is typical; may lift up to 30 lbs. occasionally.

　　Desired Qualifications* Excellent interpersonal, influencing, communication, listening, negotiating and problem-solving/decision-making skills are preferred.* Proficient in MS Office applications and data-based documentation and knowledge management systems.* Strong knowledge of statistical methods such as Six Sigma, statistical tools for data analysis. (i.e., CpK, Probability of failure), and risk management tools (FMEA, etc.).* Strong knowledge and understanding of the Root Cause Analysis tools such as brainstorming, cause and effect analysis, fishbone diagrams, 5 why's, failure mode, effect analysis, RATIO, and others as applicable.* Strong knowledge of regulatory requirements in the development, validation, and manufacture of consumer and OTC monograph drug products (regulatory agencies such as FDA, MHRA, Health Canada, AIFA, etc.).* Ability to travel may be up to 10%

　　What's In It For You* Competitive Benefit Package* Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!* Learning & Development Opportunities* Employee Resource Groups

　　Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.