Process Development Validation Scientist II

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

About This Opportunity

As a Process Development Validation Scientist, you will be responsible for drafting new Process Validation protocols and report documents to support process development, manufacturing, and validation activities. You will also draft Risk Assessment Spreadsheets.

Key Responsibilities

• Preparation of Process Validation protocols / reports, CPV protocols and reports, PC&P reports, and VMP / VSR to enable Avecia’s process validation programs to be executed efficiently.
• Preparation of Manufacturing Study Protocols and associated reports.
• Creates new Process Validation document templates.
• Drafts Risk Assessment Spreadsheets.
• Contributes to Initial and Final Risk Assessment activities.
• Contributes to investigations of OOT results during CPV and OOS/CAPA results during manufacture of validated products.
• Prepares and delivers PPQ training.
• Maintains an appropriate level of training on company and departmental procedures as determined by Avecia and Process Validation.

Required Skills/Abilities

• Bachelor’s Degree in a science-related discipline and 6+ years related experience, or Master’s degree and 3+ years related experience in a science-related discipline.
• Knowledge of ICH guidance related to GMP and Process Validation.
• Excellent written and verbal communications, including technical writing.
• Proficiency in Microsoft Office Software.
• Knowledge of statistics and its application to process sampling and data trending analysis; knowledge of Minitab and SPC preferred.

The annualized salary range for this role is $89,500.00 - $109,500.00.