Validation Engineer

SoTalent; Social Circle (GA); On-site; USD 60,000 - 75,000; Full time

Job summary

A healthcare organization is seeking an Entry-Level Validation Engineer responsible for guiding validation activities related to cleaning processes. You will manage validation protocols and ensure compliance with regulatory standards. This position involves collaboration with multiple teams and requires a Bachelor's degree in engineering. The organization promotes a culture of integrity and continuous improvement, offering employees opportunities to grow their careers through impactful work.

Qualifications

• Minimum 2 years of experience in validation is required.
• Hands-on experience developing validation protocols within regulated environments.
• Strong understanding of cGMP operations and cleaning processes.

Responsibilities

• Guide validation activities with in-depth knowledge of cGxP and GAMP5.
• Mentor peers on quality engineering approaches.
• Write protocols, ensure execution, and confirm compliance with regulations.

Skills

Leadership

Technical writing

Multi-project management

Problem-solving

Collaboration

Education

Bachelor’s degree in Engineering

Tools

Microsoft Office

FMEA

DOE

SPC

Job description

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This role is responsible for shaping and guiding the site’s approach to validation activities, particularly those involving cleaning processes. You will serve as an engineering approver for cleaning development, validation protocols, and final reporting. The position includes planning validation strategies, coordinating execution, preparing documentation, and supporting both new and recurring validation efforts.

You will also help troubleshoot manufacturing issues and evaluate opportunities for process optimization. Validation documentation may be referenced in regulatory submissions and during inspections, making accuracy and compliance crucial.

Daily collaboration with Manufacturing, Engineering, Regulatory Affairs, Quality Control, and Quality Operations is expected.

Key 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.

Qualifications

• 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.

About the Company

Their organization is committed to advancing healthcare through innovative therapies and exceptional patient support. They offer a workplace centered on collaboration, integrity, and continuous improvement. Employees are encouraged to grow their careers through meaningful work and ongoing development opportunities. Recognized globally as an employer of choice, we strive to create an inclusive environment where every team member plays a part in delivering better health solutions worldwide.

Seniority level

Entry level

Employment type

Full‑time

Job function

Industries: Engineering Services and Health and Human Services