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

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 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.