Validation Engineer

• Demonstrated experience supporting filling line and isolator qualification activities, including commissioning, validation, and lifecycle management.
• Strong understanding of industry best practices from a Commissioning, Qualification, and Validation (CQV) perspective, with the ability to apply these principles in regulated GMP environments.
• Capable of drafting, executing, and finalizing CQV documentation for standard equipment and systems (e.g., IQ/OQ/PQ protocols, summary reports, and traceability matrices).
• Experienced in developing and facilitating risk assessments (e.g., FMEA), ensuring appropriate mitigation strategies and alignment with regulatory expectations.
• Able to assume ownership of existing CAPAs (Corrective and Preventive Actions) and Change Controls (CCs), effectively driving them through investigation, implementation, and closure.
• Preferred experience working with VanRx robotic isolator systems, including qualification, troubleshooting, or operational support.
• Proficient in executing and supporting revalidation activities across a range of GMP equipment, including Controlled Temperature Units (CTUs), isolators, bioreactors, TFF and chromatography systems, and critical utility systems.
• Suitable for a Facilities GMP Technical role, with flexibility to travel between Boxborough and Watertown sites (approximately 2 days per week at each location).
• Hands-on troubleshooting experience with both facility infrastructure and process systems, including root cause analysis and implementation of corrective actions.
• Familiarity with Building Management Systems (BMS) and BMRAM or similar computerized maintenance/asset management platforms.
• Willingness to participate in an on-call rotation to support facility and process needs as required.
• Ability and willingness to obtain a specialty boiler license (if not already certified).
• Additional certifications such as wastewater operation, fork truck operation, or fireman’s license are considered a plus.

QUALIFICATIONS AND REQUIREMENTS:

Education

• Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical preferred) or a related technical field.

Experience

• 5–10 years of experience in CQV, validation engineering, facilities engineering, or a blended role.
• Strong experience supporting GMP utilities, cleanroom environments, and facility systems.
• Experience with commissioning and qualification of facility and utility systems.
• CAPEX project experience is preferred.

Knowledge, Skills, and Abilities

• Strong understanding of CQV lifecycle and validation principles.
• Knowledge of GMP regulations (FDA, EMA) and data integrity requirements.
• Experience with utilities and infrastructure systems in regulated environments.
• Familiarity with ISPE guidance and ASTM E2500 is preferred.
• Strong troubleshooting, root cause analysis, and problem-solving skills.
• Ability to develop and interpret engineering and validation documentation.
• Excellent communication, leadership, and collaboration skills.
• Highly organized and capable of balancing project-based work with ongoing operations support.

ESSENTIAL FUNCTIONS:

Physical Demands: 

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. 

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. 

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.