Validation Engineer

Gerresheimer AG; Peachtree City (GA); On-site; USD 85,000 - 115,000; Full time

Job summary

A leading company in the pharmaceutical packaging industry seeks a detail-oriented Validation Engineer to oversee validation and qualification processes. The role emphasizes compliance with regulatory standards such as ISO and FDA, requiring strong documentation skills and experience in quality assurance. The company offers significant benefits including a 401K match and education reimbursement, aimed at fostering a supportive workplace culture focused on employee wellness and continuous improvement.

Benefits

401 K Match up to 4.5%

Medical, Dental, and Vision Coverage

Education Reimbursement

Wellness Incentives

Qualifications

• 5+ years' experience in quality assurance or validation
• Deep understanding of verification and regulatory standards
• Proficiency in project management and technical reporting

Responsibilities

• Lead validation processes and ensure compliance documentation
• Manage deviations and analyze test results
• Collaborate on regulatory compliance initiatives

Skills

Project Management

Regulatory Compliance

Documentation

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Industrial Engineering

Bachelor's degree in a related technical field

Tools

Microsoft Office

Minitab

Job description

650 Highway 74 South, United States | Peachtree City | Full-time

Job Description

We’re looking for a detail-oriented and driven Validation Engineer to lead the planning, coordination, and execution of validation and qualification activities for both production and support processes. This role is essential to maintaining our high standards in compliance, documentation, and risk management in line with global regulatory requirements.

Qualifications

1. Independently plan and execute validation and qualification activities across projects
2. Analyze test results, manage deviations, and evaluate changes impacting validated states
3. Prepare and maintain comprehensive documentation in compliance with ISO and FDA standards
4. Support internal and supplier audits, customer declarations, and requalification efforts
5. Collaborate cross-functionally to support regulatory and quality compliance initiatives
6. Contribute to continuous improvement in validation processes, documentation, and best practices
7. Lead or support risk management activities during project execution

Additional Information

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Industrial Engineering, or a related technical field
• Minimum of 5 years' experience in quality assurance, qualification, and/or validation
• Deep understanding of verification, validation, and regulatory standards

Technical Expertise

• Solid knowledge of GMP, ISO 13485, ISO 14971, ISO 15378, MDR, and 21 CFR 820
• Proficiency with digital systems including MES, ERP, Microsoft Office, Minitab, and quality management tools
• Advanced knowledge of statistical and problem-solving methods (e.g., Kepner-Tregoe)
• Skilled in project management principles and writing technical reports
• Proactive, reliable, and flexible with a hands-on mindset
• Strong interpersonal skills and emotional resilience
• Excellent communication skills and ability to work well in cross-functional teams

We have a self-serve break area with drinks, snacks & light finger food for purchase.

We ensure our employees receive regular training and coaching to unleash their potential. We offer education reimbursement.

Your health and well-being are important to us. We offer benefits including: 401 K Match up to 4.5%, Medical/RX/Dental/Vision, Life LTD & STD, optional Accidental/Critical Care and Illness & Hospitalization, and optional coverage for spouse & children.

Creating a great place to work is essential for us, so we uphold our values of teamwork, responsibility, integrity, bold innovation, and excellence (TRIBE).

Wellness & other incentives

Note: Benefits may vary depending on the position.

About Gerresheimer

Gerresheimer is an innovative system and solution provider and global partner for the pharma, biotech, and cosmetics industries. The company offers a comprehensive portfolio of pharmaceutical packaging, drug delivery systems, medical devices, and digital solutions. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. With around 13,400 employees and over 40 production sites in 16 countries across Europe, America, and Asia, Gerresheimer has a global presence and produces locally for regional markets.

Equal Rights

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. All applicants are considered without regard to color, creed, religion, gender, gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status, or any other legally protected status. Preference is given to hiring people with disabilities.