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-pa...