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 (Cleaning Validation) to be in Gurabo, Puerto Rico! #LI-Onsite
The Experienced Scientist is responsible for the build, development, and lifecycle management of manufacturing and packaging equipment cleaning processes. This position serves in a dynamic, cross-functional environment and leads projects of moderate to high complexity and business criticality. The role operates in a collaborative and inclusive cross-functional environment that values different perspectives and continuous learning.
Key Responsibilities:
Lead and support cleaning validation lifecycle activities, including:
Validation of new processes
Evaluation of changes (new equipment, modifications to existing equipment, process changes, and new product introductions, among others) that could impact the validated state of the cleaning procedures
Periodic monitoring and maintenance of validated cleaning processes
Develop and implement cleaning validation strategies, ensuring alignment with regulatory expectations and internal standards
Lead execution of validation activities and coordinate cross-functional efforts (Manufacturing, Quality, Engineering, etc.)
Assess impact of changes through risk-based evaluations and define appropriate validation requirements
Identify and drive continuous improvement initiatives to improve efficiency, robustness, and compliance of cleaning processes
Represent the site in global forums, sharing standard processes and supporting deployment of corporate validation standards and initiatives
Author and review technical documentation, including validation protocols, reports, and investigations
Qualifications
Education
Bachelor’s degree with 4 or more years of relevant experience OR advanced degree (MS, MBA, PhD) with 2 or more years of relevant experience is required
Experience and Skills:
Required:
Proven experience in Manufacturing Science & Technology (MSAT), validation, or related technical support within the pharmaceutical or regulated industry
Experience in equipment cleaning validation, including lifecycle approach and regulatory expectations, preferable for equipment used for solid dosage manufacturing/packaging
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, and scientific justifications)
Proficiency in MS Office applications (Word, Excel, PowerPoint, Outlook)
Project management skills with ability to balance multiple priorities
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
Knowledge of project management tools (e.g., MS Project)
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:
Data Savvy, Detail-Oriented, Drug Discovery Development, Execution Focus, Innovation, Laboratory Experiments, Market Research, Pharmaceutical Sciences, Product Development, Product Strategies, Project Management, Report Writing, Scientific Research, Standard Scientific Processes and Procedures, Technologically SavvyWant to know if this job is worth applying to?