Quality Engineer

Select how often (in days) to receive an alert:

Requisition

Location:

Indianapolis, IN, US, 46250

Date:
Aug 7, 2026

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,Decon Box™

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

Flexy

Cult™

ESSENTIAL JOBDUTIES:

Quality

• Supportcolleaguesin draftingandfinalizingtechnical documents and the interpretation and application of legal, regulatory and project requirements
• Quality management of orders in relation to:
• Specific validation (DQ)
• Process controls
• Work with technical team in the field as well as 3rdparties at customer sites to perform and successfully complete SAT, IQ, OQ, VPHP Cycle development and VPHP PQ activities.
• Work with other colleagues to develop andmaintainquality procedures and controls atComecer
  
  Inc. facilities in North America to conform to customer and regulatory requirements.
• Work with Comecerquality personnel and 3rdparties to establish regulatory approval for Comecerdisposable 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:

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