Process Validation & Development 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

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.