Process Validation Scientist II: Protocols, Risk, CPV Lead

Nitto Avecia; Milford (MA); On-site; USD 89,500 - 109,500; Full time

Job summary

Nitto Avecia is seeking a Process Development Validation Scientist in Milford, Massachusetts. The role involves drafting Process Validation and Risk Assessment documents to support validation activities in manufacturing.

Qualified candidates should possess a Bachelor’s degree with 6+ years of relevant experience, or a Master’s with 3+ years. Knowledge of ICH guidance and proficiency in technical writing are essential. The position offers a competitive salary range of $89,500 to $109,500 annually.

Qualifications

• 6+ years related experience with Bachelor's or 3+ years with Master's.
• Strong knowledge of statistics as applied to process sampling.
• Excellent communication and technical writing skills.

Responsibilities

• Draft Process Validation protocols and reports.
• Prepare Manufacturing Study Protocols.
• Create Process Validation document templates.
• Draft Risk Assessment Spreadsheets.
• Contribute to Risk Assessment activities.
• Investigate OOT and OOS/CAPA results.
• Prepare and deliver PPQ training.
• Maintain training on company procedures.

Skills

Excellent written and verbal communications

Proficiency in Microsoft Office Software

Knowledge of ICH guidance related to GMP

Knowledge of statistics and data trending analysis

Education

Bachelor’s Degree in a science-related discipline

Master’s degree in a science-related discipline

Tools

Minitab

Job description

Nitto Avecia is seeking a Process Development Validation Scientist in Milford, Massachusetts. The role involves drafting Process Validation and Risk Assessment documents to support validation activities in manufacturing.

Qualified candidates should possess a Bachelor’s degree with 6+ years of relevant experience, or a Master’s with 3+ years. Knowledge of ICH guidance and proficiency in technical writing are essential. The position offers a competitive salary range of $89,500 to $109,500 annually.