SoTalent · 14 hours ago
Validation Engineer II
Social Circle, GA
Full-time
Onsite
Entry, Mid Level
$70K/yr - $110K/yr
2+ years expSoTalent is seeking a Validation Engineer II to provide validation strategy guidance for site-level and global projects within a regulated pharmaceutical/biotech manufacturing environment. This role involves hands-on validation activities, including protocol development and execution, while ensuring compliance with regulatory standards.
Staffing & Recruiting
Responsibilities
Develop, execute, and approve cleaning validation protocols and final reports
Lead and coordinate validation activities, including project planning and execution
Assess, validate, and revalidate manufacturing and cleaning processes
Interpret and apply cGMP, GAMP5, and 21 CFR Part 11 requirements
Review and assess change controls impacting validated systems
Partner with Engineering, Manufacturing, Quality, Regulatory, and other technical teams to define validation strategies across the system lifecycle
Ensure validation documentation meets FDA, EU, JP, and global regulatory standards
Support investigations, deviations, CAPAs, and closure of non-conformances
Apply Quality Engineering tools such as FMEA, DOE, SPC, and QbD
Identify and implement opportunities for process optimization and harmonization
Support internal and external audits and regulatory inspections, including presenting validation strategies to inspectors
Contribute to SOP development and Global Validation initiatives
Mentor peers and provide technical guidance within Validation and Engineering teams
Qualification
Required
Bachelor's degree in Engineering (Chemical, Mechanical, or Electrical preferred)
2+ years of validation experience in pharmaceutical or biotech manufacturing
Strong experience with cleaning validation and manufacturing processes
Proven ability to author and execute validation protocols, reports, and SOPs
Solid understanding of working in a cGMP-regulated environment
Hands-on experience in Manufacturing, Engineering, or Technical Services is an advantage
Strong leadership, organizational, and project management skills
Excellent technical writing and communication abilities
Proficiency in Microsoft Word, Excel, PowerPoint, Visio, and Project
Ability to manage multiple priorities and meet tight timelines independently and within cross-functional teams
Benefits
Medical, dental, and vision insurance
401(k) with company match
Short- and long-term incentives
Paid time off, holidays, and sick leave
Tuition reimbursement and well-being programs
Company
SoTalent
At SoTechTalent, we specialise in connecting forward-thinking tech companies with world-class talent.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase