SoTalent · 9 hours ago
Validation Engineer
Social Circle, GA
Full-time
Onsite
Entry, Mid Level
2+ years expSoTalent is committed to advancing healthcare through innovative therapies and exceptional patient support. The Validation Engineer role is responsible for guiding validation activities, coordinating execution, and preparing documentation while ensuring accuracy and compliance with regulatory guidelines. Daily collaboration with cross-functional teams is essential to troubleshoot manufacturing issues and optimize processes.
Staffing & Recruiting
Responsibilities
Apply in-depth knowledge of cGxP, GAMP5, 21 CFR Part 11, relevant SOPs, and internal procedures to guide validation activities
Manage multiple technical initiatives simultaneously in support of engineering and manufacturing groups
Lead or assist with complex projects requiring prioritization, coordination, and cross-functional teamwork
Evaluate change controls to determine potential effects on validated systems and processes
Complete routine validation assignments with precision and timeliness
Engage with cross-functional teams to define validation needs using lifecycle principles including user requirements, functional and design specifications, development work, and validation strategies
Write protocols and reports, ensure execution, interpret results, and confirm compliance with worldwide regulatory guidelines (e.g., FDA, EU, JP, ISO 14644, EC Annex 1, USP-NF)
Mentor peers on quality engineering approaches, including statistics-based testing and evaluation
Use tools such as FMEA, DOE, SPC, and QbD to conduct risk assessments and resolve issues
Identify opportunities to streamline validation processes or improve operational efficiency
Detect and address gaps related to validation requirements and corporate validation standards
Maintain validation plans and assessments as systems evolve
Assist with investigations, CAPA activities, and documentation updates
Support the creation or revision of SOPs to align with operational or regulatory needs
Participate in audits and inspections, ensuring timely closure of observations and presenting validation rationale when required
Contribute to corporate validation harmonization initiatives
Perform additional responsibilities as assigned by leadership
Qualification
Required
Bachelor's degree in an engineering field (Chemical, Mechanical, Electrical preferred)
Minimum of 2 years' experience in validation
Background in manufacturing and cleaning processes is required
Hands-on experience developing and executing validation protocols and SOPs within a regulated pharmaceutical or biotech setting
Strong understanding of cGMP operations; direct experience in technical services, engineering, or manufacturing is beneficial
Ability to work both independently and collaboratively across technical and non-technical groups
Demonstrated leadership, organization, and communication skills
Strong technical writing capabilities
Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, Visio, and Project
Effective multi-project management and time-management skills
Experience with problem-solving and root-cause analysis techniques
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