Validation Engineer - Equinox

Mölnlycke • Brunswick, ME

18d • $104,000 - $125,000

About The Position

Mölnlycke is investing in a major capital expansion at its Brunswick manufacturing site, introducing new production capabilities, custom-engineered equipment, and advanced manufacturing technologies. The Validation Engineer will partner with Engineering, Quality, Manufacturing, Operations, and project teams to bring new equipment and processes from concept through commercialization. The role supports equipment design reviews, factory and site acceptance testing, qualification, and process validation, with a focus on ensuring new systems are implemented, validated, and transitioned successfully into production.

The position leads and supports qualification and validation activities for new and existing manufacturing systems, develops and approves validation documentation, evaluates data, and helps ensure compliance with quality and regulatory requirements. The role also supports risk assessments, investigations, change control, and guidance and training on validation practices. The position is full-time, exempt, based in Brunswick, Maine, and involves approximately 10–20% travel. The salary range is $104,000–$125,000, with an annual bonus.

Requirements

• 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 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.

Nice To Haves

• Experience in medical device, pharmaceutical, biotechnology, or other highly regulated manufacturing.
• 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.

Responsibilities

• Lead validation activities for new manufacturing equipment and processes, including commissioning support, IQ/OQ/PQ execution, and process validation for a major capital 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 support 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.

Benefits

• Medical, dental, and vision plans available from the first day of employment.
• 401(k) plan with company match.
• Profit sharing.
• Tuition reimbursement.
• Life insurance.
• Flexible spending accounts and health savings accounts.
• Paid time off.
• Paid parental leave.
• Employee Assistance Program.
• Discounted access to entertainment and travel.
• Annual bonus.

What This Job Offers

• Job Type: Full-time