Senior Engineer Validation - 2407015701W

　　DESCRIPTION/RESPONSIBILITIES:DescriptionKenvue is currently recruiting for:Senior Engineer Cleaning Validation

　　This position reports into the Supervisor II Lab Quality in Litiz, PA.

　　What You Will DoThe Sr Process Scientist supports Manufacturing Science and Technology for a broad range of consumer cosmetics, OTC drug products, and OTC monograph drug products. Primary activities require a solid understanding of the principles of cleaning processes and material interactions while developing deeper knowledge and benchmarking with other sites. The Sr process scientist possesses a passion for innovation and continuous improvement. Working under limited direction, this individual collaborates cross-functionally with Operations, Marketing, Quality Assurance, Research and Development (R&D), and other function as needed to provide technical leadership in the design, development, and implementation of technical solutions for cost reduction and critical initiatives. This individual is expected to implement technical aspects of projects, report metrics, and interact with multi-functional teams to implement projects.

　　Additionally, the Sr Process Scientist will ensure quality and compliance through GMP training, adhere to strict compliance with procedure application, exercise the highest level of integrity in tasks performed, identify, report, and seek correction for deviations noted in the workplace and embrace a behavior of employee involvement and commitment to doing the job right the first time.

　　Key Responsibilities:* Ensure quality and compliance in all actions by:* Attending GMP / EHS&S (Environmental, Health, Safety & Sustainability) training* Adhering to strict compliance with procedures applicable to the role.* Exercising the highest level of integrity in the tasks that they perform.* In a timely and prompt manner, identifying, reporting, and seeking correction for deviations noted in the workplace.* Accepting a behavior of employee involvement and commitment to doing the job right the first time.* Uses scientific principles to resolve sophisticated technical challenges while being able to articulate complex subject matter in clear, concise terms. Seeks guidance on more complex technical challenges.* Identifies and proposes opportunities and innovations, technical solutions or optimizations that can positively impact the process or business.* Designs, coordinates, and implements project tasks per established timeline including the execution of planned experiments (i.e., sample collection, in-process testing, sample management, etc.).* Support or lead the cleaning process for New Products Introduction, Products Improvements, and new raw material qualification.* Implements requirements of the planned experimental design (i.e., sample collection, in-process testing, sample management, etc.).* Writes or may approve SOPs based on the area of experience and training. Provides technical advice on SOPs, policies, and procedures.* Prepares or may approve technical memos, reports, analyzes and summarizes data, and recommends conclusions based on scientific rationale. Reviews and approves reports and confirms conclusions based on scientific analysis and rationale.* Owns and implements change control deliverables/documentation, investigations, corrective/preventative actions, and new product release data collection and analysis.* Owns and carries out investigations related to cleaning out of specification or cleaning process deviation, stability deviation, consumer complaints, and other investigations as applicable. Conduct laboratory experimentation as needed related to investigations and root cause analysis* Leads technical activities for cleaning process improvements through data analysis, identification of critical cleaning parameters, the proposal of alternate process modifications, conducting DOE to determine the best cleaning processes, cond cting scale-up activities including pilot-scale and validation, as required.* Writes technical documentation including but not limited to Cleaning Assessment, Technical Justifications, manufacturing work instructions, INV reports, and others as applicable.* Works under limited direction. Provides direction and mentorship less seasoned scientists and co-ops* Decisions made at this level are moderate in scope and authority* May assist in process or equipment validation.

　　QualificationsRequired Qualifications* A minimum of a BS in Science or Equivalent* Generally, requires (4-6) years related experience. Previous experience in a healthcare manufacturing environment desired but not required.

　　Knowledge, Skills, and Abilities* Solid knowledge of product characteristics and their correlation with product/raw material performance and performance requirements of specific products or raw materials and the customer needs.* Solid understanding of scientific principles for liquid/semi-solid formulation development (i.e., solution, suspension, semi-solid), solid dosage development (i.e., immediate and delayed-release), and other formulation development (i.e., Nasal Spray, Eye drops, Lozenges, and sterile products), as applicable.* Understanding of the process equipment and in-process control instruments.* Strong Process knowledge in a few of the processes such as Mixing, Filling, Liquid dosage, Solid dosage, Liquid Packaging, Scale-up, Technology Transfer, Continued Process Verification, Process Development, as applicable.* Knowledge and understanding of equipment design, cleaning procedures, analytical methods, sampling requirements, and in the collection and evaluation of data, from the process design stage through commercial production.* Knowledge and ability to apply selected lean tools to a situation. Tools include- 5S, Visual Management, Mistake proofing, kanbans/ rhythm wheels, and other Lean principles.* 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.).* Solid 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.* Knowledge of regulatory requirements in the cleaning development, validation, and manufacture of consumer cosmetic and OTC monograph drug products (regulatory agencies such as, FDA, MHRA, Health Canada, AIFA etc.).* Strong analytical skills are required. Excellent technical writing skills are required. Experience with MS Word, Excel and Project software packages is required. Excellent interpersonal, influencing, communication, listening, negotiating and problem-solving/decision-making skills are preferred.

　　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.