Equipment Validation Engineer
Stark Pharma Solutions Inc · Boston, MA · 1 mo ago
On-siteQuality AssuranceContract
About the role
We are looking for an Equipment Validation Engineer to support equipment validation activities in a medical device manufacturing environment.
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.
Requirements
- 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.