Biopharma Process Development & Validation Specialist

MENTOR Technical Group Corporation; Juncos (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

MENTOR Technical Group Corporation seeks a Process Development / Validation Specialist to support process development and validation in biopharmaceutical manufacturing. You will apply your understanding of protein science to enhance process improvements, ensuring product quality.

The ideal candidate has relevant experience in formulation and aseptic filling operations, along with bilingual proficiency in Spanish and English. The position involves preparing technical documentation and collaborating with cross-functional teams in a fast-paced environment.

Qualifications

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

Responsibilities

• Support process development and validation activities in commercial biopharmaceutical manufacturing.
• Apply understanding of protein science to support process improvements and product quality.
• Utilize process monitoring tools to evaluate performance and identify optimization opportunities.
• Prepare technical documentation, protocols, and reports for regulatory audits.

Skills

Protein science knowledge

Formulation experience

Statistical analysis tools experience

Bilingual proficiency in Spanish and English

Technical writing skills

Problem-solving skills

Project management skills

Cross-functional collaboration

Tools

JMP

Job description

MENTOR Technical Group Corporation seeks a Process Development / Validation Specialist to support process development and validation in biopharmaceutical manufacturing. You will apply your understanding of protein science to enhance process improvements, ensuring product quality.

The ideal candidate has relevant experience in formulation and aseptic filling operations, along with bilingual proficiency in Spanish and English. The position involves preparing technical documentation and collaborating with cross-functional teams in a fast-paced environment.