MSAT Experienced Scientist

Johnson & Johnson Innovative Medicine•Gurabo, PR

1d•Onsite

About The Position

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 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.

Requirements

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
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

Nice To Haves

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)
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

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