Quality & Validation Engineer – Pharma/ATMP

ATS Automation Tooling Systems Inc; 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 in quality management across the full lifecycle of radiopharma, pharma and ATMP projects in North America. The role includes design reviews, FAT, SAT, IQ, OQ and PQ activities related to VPHP cycle development.

The position requires coordinating with the technical team and third parties at customer sites to perform validation activities and maintain QA controls to meet regulatory requirements.

Qualifications

• Ability to communicate efficiently and effectively with people at all levels of the organization, both verbally and in written form.
• Strong problem-solving ability.
• Hands-on and able to meet deadlines.

Responsibilities

• Support colleagues in drafting and finalizing technical documents and the interpretation and application of legal, regulatory and project requirements.
• Quality management of orders in relation to specific validation (DQ) and process controls.
• Work with technical team and third parties at customer sites to perform SAT, IQ, OQ, VPHP Cycle development and VPHP PQ activities.
• Develop and maintain quality procedures and controls at Comecer Inc. facilities in North America to conform to customer and regulatory requirements.
• Establish regulatory approval for Comecer disposable kits for sale in North America.
• Develop inspection methods to analyze product quality.
• Implement a working system to ensure conformity and accuracy in the production process.
• Ensure products comply with company and international quality standards.
• Ensure that the product conforms to the desired technical specifications and take corrective action for non-conformities.
• Plan and document control activities and inspections.
• Other duties as required.

Skills

Communication

Problem solving

Hands-on

Education

Bachelor’s degree in technical field

Tools

ISO 9001

Microsoft Office

Job description

Comecer in Indianapolis, IN seeks a Quality Engineer to support project managers in quality management across the full lifecycle of radiopharma, pharma and ATMP projects in North America. The role includes design reviews, FAT, SAT, IQ, OQ and PQ activities related to VPHP cycle development.

The position requires coordinating with the technical team and third parties at customer sites to perform validation activities and maintain QA controls to meet regulatory requirements.