Validation Engineer - Equinox
Validation EngineerLocation: Brunswick, Maine- Travel: Approximately 10-20%
- Employment Type: Full-Time, Exempt
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 DoAs 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 BringRequired 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
Information at a Glance
