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Job Description:

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.

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

Required Skills:

Preferred Skills: