Quality Engineer

ATS Corporation; Indianapolis (IN); On-site; USD 65,000 - 85,000; Full time

Job summary

Comecer Inc. is seeking a Quality Engineer to support project managers across North America, ensuring quality throughout design reviews, FAT/SAT/IQ/OQ activities, and PQ development for VPHP cycle projects in Radiopharma, Pharma and ATMP sectors.

The role involves collaboration with field teams and 3rd parties to ensure regulatory compliance, develop inspection methods, and maintain quality procedures at North America facilities. Strong documentation and ISO 9001 experience are preferred.

Qualifications

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

Responsibilities

• Draft and finalize technical documents and interpret regulatory requirements.
• Manage quality of orders including validation activities.
• Maintain and manage validation documentation.
• Oversee SAT, IQ, OQ, and PQ activities with field teams and third parties.
• Develop and maintain quality procedures and controls at Comecer Inc. facilities in North America.
• Collaborate to obtain regulatory approvals for Comecer disposable kits in North America.
• Develop inspection methods to analyze product quality.
• Implement a system to ensure production conformity and accuracy.
• Ensure compliance with quality standards and product specifications.
• Plan and document control activities and inspections.
• Perform other duties as required.

Skills

Quality Engineering

Manufacturing

ISO 9001

Regulatory Compliance

Documentation

Microsoft Office

Education

Bachelor’s degree in technical field

Tools

Microsoft Office

Job description

Job Description

The Quality Engineer 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.

The markets this position services include 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, glove testers, 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, Combo Phill aseptic filling line for RTU vials syringes, cartridges, fully automated combination product end-to-end filling systems, Speedy Glove, DeconBox

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

Additional Information

ESSENTIAL JOB DUTIES:

Quality

• 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)

• Validation documentation

• Process controls

• 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

• Other duties as required.

Qualifications

QUALIFICATIONS:

• Bachelor’s degree in technical field or equivalent experience.

• Quality Engineering experience in a manufacturing environment preferred.

• Experience with International Standardization Organization (ISO) standards 9001preferred.

• Ability to communicate efficiently and effectively with people at all levels of the organization, both verbally and in written form.

• Strong problem-solving ability.

• Proficient in Microsoft Office suite.

• Must be hands-on and must be able to meet deadlines for his or her responsibilities either directly or indirectly.

JOB SPECIFICATIONS:

• The employee may be required to stand, walk, push, pull, reach overhead, and bend to the floor.

• Exert up to 50 pounds of force occasionally, and/or exert up to 10 pounds of force frequently.

• Visual acuity – Normal requirements for reading written instructions and computer screens.

• Hearing ability – Normal requirements for understanding verbal instructions.

• Working conditions – The employee is subject to a normal office environment with occasional exposure to high noise levels and/or physical hazards when visiting the manufacturing floor.

• Capable of wearing appropriate related PPE for extended periods of time.