Quality Engineer – Validation & Compliance for Pharma/ATMP

Comecer; Indianapolis (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

Comecer in Indianapolis, IN seeks a Quality Engineer to support Project Managers by managing orders from a quality perspective, including design reviews, FAT, SAT, IQ, OQ and VPHP cycle development for Radiopharma, Pharma and ATMP projects in North America.

You will work with cross-functional teams to ensure regulatory compliance, prepare validation documentation, develop inspection methods, and maintain quality procedures at Comecer facilities in North America while meeting deadlines.

Qualifications

• Bachelor’s degree in a technical field or equivalent experience.
• Quality Engineering experience in a manufacturing environment preferred.
• Experience with ISO 9001 standards preferred.
• Ability to communicate effectively at all levels of the organization, both verbally and in writing.
• Strong problem-solving ability.

Responsibilities

• Draft and finalize technical documents and interpret/apply regulatory and project requirements.
• Quality management of orders including validation activities (DQ/ IQ/ OQ/ PQ).
• Perform SAT, IQ, OQ and VPHP cycle development activities with project teams.
• Develop and maintain quality procedures and controls at Comecer NA facilities.
• Coordinate regulatory approvals for Comecer disposable kits in North America.
• Develop inspection methods to analyze product quality and ensure conformity in production.

Skills

Quality Engineering

Problem solving

Communication

Microsoft Office

Education

Bachelor's degree in technical field

Job description

Comecer in Indianapolis, IN seeks a Quality Engineer to support Project Managers by managing orders from a quality perspective, including design reviews, FAT, SAT, IQ, OQ and VPHP cycle development for Radiopharma, Pharma and ATMP projects in North America.

You will work with cross-functional teams to ensure regulatory compliance, prepare validation documentation, develop inspection methods, and maintain quality procedures at Comecer facilities in North America while meeting deadlines.