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About Innovative Medicine

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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

• Bachelors 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

Required Skills:

Preferred Skills: