Validation Engineer (Relocate to Fall River, MA) jobs in United States
cer-icon
Apply on Employer Site
company-logo

Confidential · 3 hours ago

Validation Engineer (Relocate to Fall River, MA)

positionUnited States
timeFull-time
remoteRemote
seniorityMid Level
money$62K/yr - $95K/yr
date3+ years exp

Confidential company is seeking a Validation Engineer – Manufacturing to support qualification, validation, and documentation activities within a cGMP-regulated pharmaceutical manufacturing environment. The role involves preparing, executing, and maintaining validation documentation while collaborating cross-functionally with various teams to ensure compliance and operational excellence.

Chemicals
Hiring Manager
Kapil Sharma
linkedin

Responsibilities

Prepare and execute qualification and validation protocols (IQ, OQ, PQ)
Develop and maintain validation plans, reports, and GMP documentation
Support cleaning validation and process validation programs
Lead equipment and system qualification activities (URS, DQ, FAT, SAT, etc.)
Author and revise SOPs, batch records, and documentation templates
Participate in deviation investigations, CAPA, and change control processes
Conduct root cause analysis and continuous improvement initiatives
Track validation metrics and periodic reviews
Support internal and regulatory audits
Ensure compliance with cGMP, GDP, and FDA requirements
Work independently while collaborating with cross-functional teams

Qualification

Validation experienceGMP documentationPharmaceutical manufacturingFDA regulations knowledgeTechnical writingMicrosoft OfficeAnalytical skillsLean knowledgeSAP experienceProblem-solving skills

Required

Associate or Bachelor's degree in Science, Engineering, Pharmaceutical Sciences, or related field
3+ years of validation or GMP documentation experience
Experience in pharmaceutical or biotech manufacturing
Knowledge of equipment, process, and cleaning validation
Familiarity with FDA regulations and 21 CFR compliance
Strong technical writing and documentation skills
Proficiency with Microsoft Office (Word, Excel, PowerPoint)
Strong analytical and problem-solving skills

Preferred

Experience with inhalation/MDI products
SAP or electronic quality systems experience
Audit support experience
Lean or continuous improvement knowledge

Company

Confidential

twitter
company-logo
location
Alexandria, EG
people-size501-1000 employees

Funding

Current Stage
Late Stage
Company data provided by crunchbase