The Role
Support formulation and aseptic filling operations in a commercial biopharmaceutical manufacturing environment. Monitor processes, trend data, perform statistical analysis (JMP), investigate deviations, conduct root cause and product impact assessments, provide manufacturing floor support (including irregular shifts), prepare regulatory audit documentation, and collaborate cross-functionally. Bilingual English/Spanish communication 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 Master’s + 2 years of Scientific experience
Alternatively, Bachelors + 4 years of Scientific experience
Work schedule: 8:00 am to 5:00 pm (admin shift). However, staff will support a 24/7 formulation and filling operations, and irregular shifts, including extended hours (12 hrs), nights, weekends, or holidays may be required based on business needs.
Skills Required
- 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, including irregular shifts and extended hours.
- 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.
- Education: Doctorate OR Master's plus 2 years scientific experience OR Bachelor's plus 4 years scientific experience.
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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.
