What are the responsibilities and job description for the Validation Engineer position at Premier Life Sciences LLC?
Job Title: Equipment Validation Engineer
Location: Boston, MA
Duration: 12 Months - Onsite
**Only W2/1099 - No C2C - Onsite Interview**
Client Overview:
Our client, a leading medical equipment manufacturer, is seeking an Equipment Validation Engineer to ensure compliance, functionality, and reliability of GMP equipment and facilities. This role involves managing equipment validation activities, troubleshooting issues, and maintaining documentation to meet stringent regulatory standards.
Key Responsibilities:
- Develop, review, and update Equipment Requirements Specifications (URS) and SOPs.
- Plan and execute equipment qualification protocols, including IQ/OQ/PQ.
- Manage calibration, maintenance, and validation schedules in compliance with GMP standards.
- Coordinate with suppliers for installation, servicing, and troubleshooting of equipment.
- Conduct root cause analyses for equipment failures and implement corrective actions.
- Support CAPA investigations and documentation of quality system requirements.
- Collaborate with cross-functional teams to drive continuous improvement initiatives.
Qualifications:
- Bachelor’s degree in Engineering or related technical field.
- 3 years of experience in equipment validation, preferably in the medical device or pharmaceutical industry.
- Strong understanding of GMP standards and regulatory requirements.
- Technical aptitude with experience in troubleshooting and problem-solving.
- Effective communication and collaboration skills.
