Process Development Validation Scientist II jobs in United States
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Nitto Avecia · 3 days ago

Process Development Validation Scientist II

positionMilford, MA
timeFull-time
remoteOnsite
seniorityMid, Senior Level
money$90K/yr - $110K/yr
date6+ years exp

Nitto Avecia is a company focused on process development and validation. As a Process Development Validation Scientist II, you will draft new process validation protocols and reports, and support various validation activities while ensuring compliance with industry standards.

BiotechnologyManufacturingPharmaceutical
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H1B Sponsor Likelynote

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
Maintain an appropriate level of training on company and departmental procedures as determined by Avecia and Process Validation

Qualification

Process ValidationGMP KnowledgeStatisticsTechnical WritingMicrosoft OfficeVerbal CommunicationWritten Communication

Required

Bachelor's Degree in science-related discipline and 6+ years related experience, Master's degree and 3+ years related experience in science-related discipline
Knowledge of ICH guidance related to GMP and Process Validation
Excellent written and verbal communications, including technical writing
Microsoft Office Software
Knowledge of statistics and its application to such aspects as process sampling and data trending analysis

Preferred

Knowledge of Minitab and SPC

Company

Nitto Avecia

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Oligonucleotides are giving rise to a new generation of therapeutics—and Nitto Avecia is helping lead the way.
dateFounded in 1995
location
Milford, Massachusetts, USA
people-size501-1000 employees
web-link
http://www.avecia.com

H1B Sponsorship

Nitto Avecia has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (7)
2023 (6)
2022 (10)
2021 (11)
2020 (5)

Funding

Current Stage
Late Stage
Total Funding
unknown
2011-02-03Acquired
Company data provided by crunchbase