Equipment Validation Engineer – Medical Device Manufacturing

Stark Pharma Solutions Inc; Boston (MA); On-site; USD 100,000 - 140,000; Full time

Job summary

Stark Pharma Solutions Inc. in Boston, MA seeks an Equipment Validation Engineer to support validation activities in a medical device manufacturing environment.

The role involves hands-on IQ/OQ/PQ for new and existing equipment, installation and calibration, and collaboration with cross-functional teams on-site. The successful candidate will prepare validation documents, maintain SOPs, and contribute to risk assessments and safety documentation while ensuring regulatory compliance and rigorous

Qualifications

• Bachelor's degree in Engineering or related field.
• 5+ years of equipment validation experience.
• Strong knowledge of IQ/OQ/PQ.
• Experience with equipment installation and calibration.
• Experience with equipment qualification and commissioning.
• Knowledge of EHS standards and risk assessments.
• Strong technical writing and documentation skills.
• Experience with SOPs and training documentation.
• Strong communication and teamwork skills.

Responsibilities

• Perform IQ/OQ/PQ activities for new and existing equipment.
• Support equipment installation and calibration.
• Support equipment qualification and commissioning.
• Prepare and maintain validation documents.
• Create and update SOPs and equipment records.
• Prepare risk assessments and safety documents.
• Create equipment safety procedures and training manuals.
• Work with Manufacturing, Quality, Engineering, and EHS teams.
• Support equipment validation activities on the manufacturing floor.
• Ensure equipment activities meet quality and regulatory requirements.

Skills

IQ/OQ/PQ

Equipment installation

Calibration

Equipment qualification

Commissioning

SOPs

Training documentation

EHS risk assessments

Technical writing

Communication

Teamwork

Education

Bachelor's degree in Engineering

Job description

Stark Pharma Solutions Inc. in Boston, MA seeks an Equipment Validation Engineer to support validation activities in a medical device manufacturing environment.

The role involves hands-on IQ/OQ/PQ for new and existing equipment, installation and calibration, and collaboration with cross-functional teams on-site. The successful candidate will prepare validation documents, maintain SOPs, and contribute to risk assessments and safety documentation while ensuring regulatory compliance and rigorous