Process Development Validation Scientist II

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

Job summary

Avecia Pharma is seeking a Process Development Validation Scientist II to draft and manage Process Validation protocols and reports across development, manufacturing, and validation activities. You will also contribute to risk assessments and data analysis using statistical tools.

Ideal candidates hold a science degree with 6+ years of related experience (or a Master’s with 3+ years) and have strong written and verbal communication skills, plus proficiency in MS Office and statistical software.

Qualifications

• Bachelor’s or Master’s degree in a science-related discipline with related experience.
• Experience in GMP, ICH guidelines, and process validation.
• Strong written and verbal communication, including technical writing.
• Proficiency in Microsoft Office software.
• Knowledge of statistics and its applications to process sampling and data trending, with Minitab/SPC preferred.

Responsibilities

• Prepare Process Validation protocols and reports, CPV protocols and reports, PC&P reports, and VMP/VSR.
• Prepare Manufacturing Study Protocols and related reports.
• Contribute to Initial and Final Risk Assessment activities.
• Investigate OOT results during CPV and OOS/CAPA results during manufacture of validated products.
• Prepare and deliver PPQ training.
• Maintain appropriate training on company and departmental procedures.

Skills

Technical writing

Microsoft Office

Statistics

SPC

Data analysis

Process validation

Education

Bachelor’s degree in a science-related discipline

Master’s degree in a science-related discipline

Tools

Minitab

Job description

Process Development Validation Scientist II

About this opportunity

As a Process Development Validation Scientist, you will be responsible for drafting new Process Validation protocol and report documents to support process development, manufacturing, and validation activities. Responsible for drafting 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.
• 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.
• Maintain 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, 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 such aspects as 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.