The Role
Support formulation and aseptic filling operations in commercial biopharmaceutical manufacturing. Monitor processes, trend data, perform statistical analysis, investigate deviations, conduct root cause and product impact assessments, provide 24/7 manufacturing floor support, prepare regulatory audit documentation, and collaborate cross-functionally. Bilingual Spanish/English and strong technical writing and project management skills required.
Summary Generated by Built In
• Relevant experience in a commercial biopharmaceutical manufacturing environment, preferably supporting formulation and aseptic filling operations.
• 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 manufacturing floor support in a fast-paced, 24/7 operation.
• 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 skills and cross-functional collaboration skills.
Requirements
Doctorate OR Masters + 2 years of Scientific experience
OR Bachelors + 4 years of Scientific experience.
Preferred:
Educational background in Life Sciences or Engineering (Biochemistry, Chemical Engineering, etc.).
Skills Required
- Relevant experience in a commercial biopharmaceutical manufacturing environment, preferably supporting formulation and aseptic filling operations.
- 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 manufacturing floor support in a fast-paced, 24/7 operation.
- 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 skills and cross-functional collaboration skills.
- Doctorate OR Master’s + 2 years of Scientific experience OR Bachelors + 4 years of Scientific experience.
- Educational background in Life Sciences or Engineering (Biochemistry, Chemical Engineering, etc.).
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The Company
What We Do
ISPV Inc. is a Life Science company that leads Productivity & Validation projects for the Pharmaceutical and Food industries.
