ATS Company: Comecer

Requisition ID: 12755

Location:

Indianapolis, IN, US, 46250

Date: Oct 26, 2024

Quality Engineer

This individual supports Comecer Project Managers in the management of the orders from a quality point of view throughout the project including design reviews, FAT, SAT, IQ, OQ and some aspects of PQ as they relate to VPHP cycle development.

This position will include activities for Radiopharma, Pharma and Cell & Gene Therapy (ATMP) projects in North America; including, but are not limited to:

• Radiopharma – shielded hot cells and automation, synthesis and dispensing modules for vials and syringes, LAF shielded isolators, sterility testing isolators, VPHP generators for sterilization, solid target processing systems, dose calibrators, and VPHP sterilization modules

• Pharma – aseptic handling and filling of liquid and powder APIs, dispensing custom R&D isolators, potent API processing Isolators (PAPI), modular sterility testing isolators (MSTI), ATEX isolators, Baby Phill small batch vial filling, Aseptic filling line for RTU vials syringes, cartridges, fully automated combination product end-to-end filling systems, Speedy Glove™, SuperTrak™ Pharma Flow Fillers

• Cell & Gene Therapy (ATMP) – modular cell culture isolator (MCCI), incubation system for advanced therapy labs FlexyCult™, ValueCell Fill

Key Responsibilities:

Quality

• Support colleagues in drafting and finalizing technical documents and the interpretation and application of legal, regulatory and project requirements

• Work with technical team in the field as well as 3rd parties at customer sites to perform and successfully complete SAT, IQ, OQ, VPHP Cycle development and VPHP PQ activities.

• Work with other colleagues to develop and maintain quality procedures and controls at Comecer Inc. facilities in North America to conform to customer and regulatory requirements.

• Work with Comecer quality personnel and 3rd parties to 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 compliance with company and international quality standards

• Ensure that the product corresponds to the desired technical specifications and take corrective action to resolve non-conformities

• Plan and document control activities and inspections

Qualifications:

• Bachelor’s degree or post-secondary education in Quality Control, Engineering, Nuclear Medicine, or Microbiology.

• Technical or engineering experience required, aseptic processing and containment strongly preferred

• Previous experience in similar role required

• Knowledge of quality management systems and procedures

• Knowledge of methods to apply to resolve non-conformities

• Knowledge of regulations applicable to Comecer products and certification processes.

• Ability to work effectively with internal, cross-functional teams and customers according to deadlines and under pressure-filled conditions.

• Self-driven, attentive to detail, consistent, and process driven.

• Fluent in English, written and oral, fluent in Italian is an asset

• Excellent time-management skills and ability to efficiently coordinate multiple projects at a time.

• Proficient with Microsoft software tools including Outlook, Project, Word, Excel, and Power Point

• Must be eligible and able to travel domestically & internationally within 30 days from hire date and legally eligible to operate a vehicle, as this is an essential job function.