Validation Engineer

Location: Brunswick, Maine

• Travel: Approximately 10-20%
• Employment Type: Full-Time, Exempt

Help Shape the Future of Manufacturing at Mölnlycke

Mölnlycke is making a significant investment in the future of our Brunswick manufacturing site through a major capital expansion initiative. As we introduce new production capabilities, custom-engineered equipment, and advanced manufacturing technologies, we're looking for a Validation Engineer who wants to be at the center of that transformation.

This is more than a traditional validation role. You'll partner with Engineering, Quality, Manufacturing, and project teams to bring new equipment and processes online from concept through commercialization. From equipment design reviews and factory acceptance testing to qualification and process validation, you'll play a critical role in ensuring our next generation of manufacturing capabilities is built for long-term success.

What Makes This Opportunity Unique

• Support a high-visibility capital expansion project that will shape the future of manufacturing at our Brunswick site
• Work with brand-new production equipment, automation, and manufacturing technologies
• Influence validation strategies and qualification activities from equipment design through implementation
• Partner with cross-functional teams across Engineering, Manufacturing, Quality, and Operations
• Gain exposure to large-scale capital investments and strategic business initiatives
• Join a growing organization committed to long-term investment and continuous improvement

What You'll Do

As a Validation Engineer, you will lead and support equipment qualification and process validation activities for new and existing manufacturing systems. A major focus of the role will be supporting capital projects and ensuring new equipment and processes are successfully implemented, validated, and transitioned into production.

Key Responsibilities

• Lead validation activities for new manufacturing equipment and processes, including commissioning support, IQ/OQ/PQ execution, and process validation as part of a major CAPEX expansion project
• Develop, execute, and approve validation protocols, reports, and supporting documentation
• Support the introduction and qualification of custom-built manufacturing equipment and new production technologies
• Partner with Engineering during equipment design, installation, factory acceptance testing (FAT), and site acceptance testing (SAT)
• Conduct statistical analysis and data evaluation to support validation studies and decision-making
• Perform risk assessments and ensure validation activities align with quality and regulatory requirements
• Investigate validation-related deviations and support root cause analysis and corrective actions
• Collaborate with Manufacturing, Quality, Operations, and project teams to drive successful project execution
• Support change control activities and assess the impact of process, equipment, or system modifications
• Provide guidance and training on validation requirements and best practices

Compensation & Benefits:

This role offers a salary range of $104,000 - $125,000 with an annual bonus.

Offers of employment consider various factors including experience, education, location, and role-specific requirements.

Our comprehensive benefits package is designed to support your health, financial well-being, and work-life harmony:

• Medical, dental, and vision plans are available from your first day of employment and provide extensive coverage through multiple options so you can find the right fit for you and your family.
• Financial benefits include a robust 401(k) plan with company match, profit sharing, tuition reimbursement, life insurance and both flexible spending accounts and health savings accounts.
• Molnlycke offers generous paid time off, paid parental leave, an Employee Assistance Program and lifestyle perks like discounted access to entertainment and travel

What You'll Bring

Required Qualifications

• Experience performing equipment qualification and process validation activities in a regulated manufacturing environment
• Strong knowledge of validation methodologies, risk management, and statistical analysis
• Experience writing and executing validation protocols and reports
• Understanding of quality systems and regulatory requirements within a regulated industry
• Strong problem-solving skills and the ability to manage multiple priorities in a project-driven environment
• Effective communication and collaboration skills with cross-functional stakeholders
• Bachelor's degree in Engineering, Life Sciences, or a related technical field preferred

Preferred Qualifications

• Medical device, pharmaceutical, biotechnology, or other highly regulated manufacturing experience
• Experience supporting capital projects, facility expansions, or new equipment implementation
• Knowledge of FDA regulations, cGMP, and ISO 13485 requirements
• Experience with statistical software such as Minitab or JMP
• Familiarity with automated manufacturing equipment and production systems
• Experience participating in cross-functional project teams from concept through commercialization

Our approach to diversity and inclusion

At Molnlycke, diversity is not just a vision, but our strength. We are dedicated to fostering an inclusive workplace that values and celebrates the power of diversity. At the heart of our commitment is the belief that diversity fuels innovation, creativity, and problem-solving. We invite you to be a part of a team where authenticity is embraced and every employee, regardless of background or any other traits, experiences a true sense of belonging. Your attitude, drive, enthusiasm, and eagerness to learn are just as important to us as the requirements for the role.

About Mölnlycke

Mölnlycke is a world-leading medical products and solutions company that equips healthcare professionals to achieve the best patient, clinical and economic outcomes.

Our business is organized into four business areas: Wound Care, Operating Room Solutions, Gloves and Antiseptics. Customer centricity, sustainability, and digitalization are at the heart of everything we do.

Mölnlycke employs around 8,400 people. The company headquarters are in Gothenburg, Sweden and we operate in more than 100 countries worldwide. Since 2007, the company has been part of Investor AB, an engaged owner of high-quality, global companies which was founded by the Wallenberg family in 1916. For more information, please visit www.molnlycke.com and www.molnlycke.com/careers