Process Development / Validation Specialist

Mentor Technical Group (MTG) provides technical support and solutions for the FDA-regulated life sciences industry. With offices in Caguas, Puerto Rico, and Boston, United States, we serve clients in six global markets, including the United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Responsibilities:

• Support process development and validation activities in commercial biopharmaceutical manufacturing, with emphasis on formulation and aseptic filling operations.

• Apply understanding of protein science, formulation, and filling processes to support process improvements and product quality.

• Utilize process monitoring, data trending, and statistical analysis tools (e.g., JMP) to evaluate process performance and identify opportunities for optimization.

• Support deviations, investigations, root cause analysis, and product impact assessments.

• Provide on-floor manufacturing support in a fast-paced, 24/7 operational environment.

• Prepare technical documentation, protocols, and reports for internal purposes and regulatory audits.

• Collaborate cross-functionally with QA/QC, production, and engineering teams to ensure compliance and process excellence.

• Communicate effectively, presenting findings and recommendations to stakeholders.

Qualifications / Requirements / Knowledge / Education / Skills:

• Relevant experience in commercial biopharmaceutical manufacturing, preferably supporting formulation and aseptic filling operations.

• Strong understanding of protein science, formulation, and filling processes.

• Experience with process monitoring, data trending, and statistical analysis tools (e.g., JMP).

• Experience supporting deviations, investigations, root cause analysis, and product impact assessments.

• Ability to provide on-floor manufacturing support in fast-paced, 24/7 operations.

• Bilingual proficiency in Spanish and English (written and verbal).

• Strong technical writing skills with experience preparing documentation for regulatory audits.

• Excellent communication, presentation, problem-solving, project management, and cross-functional collaboration skills.

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.

Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.