Gurabo, Puerto Rico, United States of America, United States of America
Onsite
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:
Pharmaceutical Product R&DJob Category:
Scientific/TechnologyAll Job Posting Locations:
Gurabo, Puerto Rico, United States of AmericaJob Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine.
We are searching for the best talent for an MSAT Experienced Scientist to be in Gurabo, Puerto Rico! #LI-Onsite
The MSAT Experienced Scientist is an established and productive individual contributor in a scientific field, who can effectively apply theoretical knowledge. Possess extensive job knowledge and is a dept at solving problems that necessitate data analysis. Leads and implements projects focused on manufacturing, packaging, and cleaning validations, conducts technical studies and medium-complexity investigations, and actively collaborates on process improvement initiatives. This position serves in a dynamic, cross-functional environment and leads projects of moderate complexity and business criticality. The role operates in a collaborative and inclusive cross-functional environment that values different perspectives and continuous learning.
Key Responsibilities:
Assess technical projects and developing strategies and plans for their execution. Coordinate project activities with site functional groups and lead projects of medium complexity.
Assess impact of changes through risk-based evaluations and define appropriate validation requirements. Develop and/or review validation protocols in compliance with applicable standards and procedures.
Lead execution of validation activities and coordinate cross-functional efforts (Manufacturing, Quality, Engineering, etc.)
Analyze and interpret results from physical and analytical testing to deliver clear, concise, and scientifically sound technical reports summarizing key findings and conclusions.
Proactively identify, evaluate, and investigate issues or deviations encountered during validation activities, and provide data-driven recommendations to ensure timely and compliant resolution.
Work with other teams to address technical issues, using scientific reasoning and expertise, connect with technical authorities as needed. Identify corrective and preventive actions with the team, using root cause analysis tools and evaluate the effectiveness of the corrective actions.
Author and review technical documentation, including validation protocols, reports, investigations and risk assessments.
Identify areas of process improvement and lead the improvement initiatives depending on their complexity.
Represent the site in global forums, sharing standard processes and supporting deployment of corporate validation standards and initiatives
Participates in audits and supporting product/process requests from regulatory agencies.
The incumbent does not have supervisory responsibilities; however, it is expected to coordinate group activities and lead projects.
Qualifications
Education
Bachelor’s degree with 4+ years of experience OR 2+ years of experience with advanced degree MS/MBA/Ph.D.
Experience and Skills:
Required:
Proven experience in Manufacturing Science & Technology (MSAT), validation, or related technical support within the pharmaceutical or regulated industry
Experience in solid oral dosage manufacturing technologies, encompassing lifecycle process validation (Process Design, Process Qualification, and Continued Process Verification), with strong knowledge of global regulatory expectations
Experience with change control processes, including assessment of equipment, process, or product changes and determination of revalidation or monitoring requirements using a risk-based approach
Experience handling deviations, investigations, and CAPAs related to validation activities, including root cause analysis and effectiveness checks.
Technical writing skills (i.e., validation protocols, investigations, reports, scientific justifications and risk assessments)
Proficiency in MS Office applications (Word, Excel, PowerPoint, Outlook)
Demonstrated knowledge of statistical methodologies, including descriptive statistics, process capability analysis (Cp, Cpk/Ppk), and trend analysis, with practical experience using Minitab (or equivalent statistical software)
Preferred:
Degree in Science, Engineering, Chemistry, Pharmacy, or a related scientific field
Experience with quality risk management tools (i.e., FMEA, risk assessments)
Experience supporting regulatory inspections and audits (e.g., FDA, EMA, PIC/S), including responding to technical questions of the validation strategy
Project management skills with ability to balance multiple priorities. Knowledge of project management tools (e.g., MS Project).
Experience with modeling and PAT
Other:
Bilingual proficiency in Spanish and English (written and verbal)
Flexibility to cross-train and support multiple validation areas
Ability to work extended hours, weekends, or holidays, as business needs require, with appropriate planning and flexibility
Availability to travel domestically and internationally, up to 10% of the time
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check
Required Skills:
Preferred Skills:
Analytical Reasoning, Controls Compliance, Detail-Oriented, Good Manufacturing Practices (GMP), Lean Supply Chain Management, Proof Reading Software, Quality Assurance (QA), Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Technologically SavvyWant to know if this job is worth applying to?