Staff Scientist

A Johnson & Johnson Consumer, Inc., a member of The Johnson & Johnson's Family of Companies, is recruiting for a Staff Scientist, located in Las Piedras, PR. The 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 Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. The position provides technical support, including formulation and process development activities, characterization, confirmation, process performance qualification, and continued process verification associated with Technology Transfer projects, and ongoing process optimization for commercialized products. This position is also responsible for product/process investigations, technical evaluations, continuous process verification (CPV), annual product reviews (APR), implementing CAPA (Corrective Actions Preventive Actions), Global Change Controls, GCC action items, compliance actions, Quality/Compliance metrics, process monitoring systems, cleaning monitoring, participating in validation governance, preparing project plans (as applicable), maintenance of validation master plans and its supplements. Responsibilities: Ability to collaborate with and influence manufacturing site leadership teams regarding prioritization and resourcing Ability to advise, connect with, and influence Management regarding validated state of respective products/processes and indicated priorities Application of pharmaceutical/OTC product solids processing including strategies for continuous improvement Ability to manage multiple projects; to periodically assess and re-direct resources as indicated in a multifaceted environment Ability to provide leadership in problem-solving and decision-making, technically advice business partner leaders with a focus on data, science, and technology Tight-knit teamwork, fast learner, communication, and presentation skills Qualifications Bachelor of Science degree (or equivalent) in Engineering, Chemistry, Pharmacy or related technical area with 6 years of pharmaceutical manufacturing related experience Knowledge of GMPs, ICH, CFR is required. Experience with regulatory agency inspections (e.g. FDA, MHRA, etc.) is helpful. Bilingual (English and Spanish) with excellent verbal, writing and technical writing skills in both languages. Ability to interpret and apply current Good Manufacturing Practices. Mathematical and analytical thinking skills. Preferred : Knowledge in SAP inventory system transactions, validation processes, statistical process control, knowledge of sampling process, regulatory audits, root cause analysis and quality risk management. Knowledge in technical transfer, product development cleaning and process validations are preferred. Proficient in cGMPs, spreadsheet applications (e.g. EXCEL), and data based documentation systems preferred. Knowledge in statistical analysis with familiarity in statistical software (e.g. Minitab, etc.) is preferred. Will work on technical decisions and evaluation of sophisticated issues based on available facts while meeting established goals and priorities. Able to work with minimum supervision, under pressure and scrutiny. Demonstrated leadership: Takes initiative and makes good judgment in the performance of duties. Ability to communicate effectively with personnel. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com Primary Location United States-Puerto Rico-Las Piedras- Organization McNeil Healthcare LLC (7598) Job Function Engineering Requisition ID 2206050063W