MSAT Experienced Scientist (Cleaning Validation)
Johnson & Johnson•Gurabo, PR
•Onsite
About The Position
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
Benefits
- Inclusive work environment
- Respect for diversity and dignity of employees
- Recognition of employee merit
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
