Validation Engineer II

Location:

• Initial training Boston, MA and then relocation to Braintree, MA

Work Schedule:

• On-site 5 days a week

Position Type: Full-Time

Job Overview:
We are seeking an Equipment Engineer to support the maintenance and optimization of state-of-the-art GMP facilities and equipment. The ideal candidate will be responsible for ensuring the proper operation, calibration, and maintenance of manufacturing equipment, while adhering to standard operating procedures (SOPs) and industry regulations. This role involves troubleshooting, testing, and working closely with cross-functional teams to drive continuous improvements in our equipment management processes.

This position will require working at both our Boston and Braintree locations, so candidates must be comfortable with travel between these sites. Interviews will include one phone screen and one on-site interview.

Key Responsibilities:

• Author and review SOPs (both new and existing)
• Create and review Equipment Requirements Specifications
• Document calibration and maintenance requirements, generate procedures
• Support the Equipment Management Program
• Schedule and collaborate with suppliers to perform service, installation, calibration, and maintenance activities
• Troubleshoot manufacturing issues, identify root causes, and implement corrective actions
• Execute Equipment Impact Assessments on equipment failures
• Participate in continuous improvement efforts and collaborate with cross-functional teams
• Provide technical communication within the team and support on-the-job training initiatives

Additional Responsibilities:

• Execute Equipment Qualification Protocols
• Perform investigations and support Corrective and Preventive Actions (CAPAs) as necessary
• Ensure proper documentation for compliance with quality systems and regulations
• Assist in ensuring compliance with applicable industry standards and regulations
• Other duties as assigned by management

Desired Qualifications:

• Bachelor’s degree in Engineering or a related technical field
• 2-4 years of experience in equipment maintenance and calibration activities, preferably in regulated industries such as medical devices or pharmaceuticals
• Strong technical aptitude and problem-solving skills
• Ability to work independently and within a team environment
• Exceptional attention to detail and record-keeping skills
• Machine shop experience is a plus
• Excellent communication skills with the ability to work across departments

Additional Information:

• Interviews will consist of one phone screen followed by an on-site interview.