Process Development / Validation Specialist
On-site · Boston, Massachusetts, United States or Caguas, Caguas, Puerto Rico
Job Summary
Support process development and validation activities in commercial biopharmaceutical manufacturing, with emphasis on formulation and aseptic filling operations. Apply protein science knowledge 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.
Required Qualifications
- Relevant experience in commercial biopharmaceutical manufacturing
- 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
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