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FDA jobs in Bloomington, IN

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Job alert Jobs 1 - 10 of 22

Manufacturing Quality Engineer 2

Cook Group  –  Bloomington, IN
... FDA, Notified Body, etc.) - Drive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams including engineering, production, clinical, and regulatory affairs. - Provide leadership in the ... - Apr 27

Process Engineer - Aseptic Filling

Catalent  –  Bloomington, IN
... Technical expertise in and support to ensure compliance with industry standards and regulatory requirements, such as FDA, ISO, and cGMP. Participating in validation activities, including IQ/OQ/PQ protocols, to ensure the effectiveness and ... - May 04

Manufacturing Quality Engineer 2

Cook Medical  –  Bloomington, IN, 47404
... FDA, Notified Body, etc.)- Drive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams including engineering, production, clinical, and regulatory affairs.- Provide leadership in the understanding ... - Apr 26

COOK Medical Fall Post Market Engineering Co-op - Bloomington, IN

Cook Medical  –  Bloomington, IN, 47404
... Mentors are chosen from Engineers and all mentors are responsible for guidance for their CO-OPs• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements• Must maintain ... - Apr 13

COOK Medical Fall Manufacturing Engineering Co-op - Bloomington

Cook Medical  –  Bloomington, IN, 47404
... Mentors are chosen from Engineers and all mentors are responsible for guidance for their CO-OPs• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements• Must maintain ... - Apr 13

Engineer, Process Engineering

Catalent  –  Bloomington, IN
... The Role: Support selection and installation of manufacturing equipment Proactively and effectively partner with the facility commissioning/validation team, including operational protocol development, to implement compliance with FDA GMP ... - May 04

Senior Engineer, Engineering - Facilities & Utilities

Catalent  –  Bloomington, IN
... Support selection and installation of manufacturing equipment Proactively and effectively partner with the facility commissioning/validation team, including operational protocol development, to implement compliance with FDA GMP requirements Draft ... - May 08

Senior Engineer - Process Engineering

Catalent  –  Bloomington, IN
... with the facility commissioning/validation team, including operational protocol development, to implement compliance with FDA GMP requirements Draft SOPs for building operation, maintenance, and calibration Identify improvements and efficiencies ... - May 05

Manufacturing Engineer 1

Cook Medical  –  Bloomington, IN, 47403
... For example, HVAC certifications, generally accepted accounting principles · Fundamental understanding engineering principles · Mechanical aptitude · ISO 13485:2016 · CFR, FDA, OSHA, environmental regulations Skills Measurable learnings (i.e. can ... - Apr 14

Senior Manager Quality Assurance

Cook Medical  –  Bloomington, IN
... Master's degree preferred- 10+ years experience in quality systems- 5+ years experience in FDA-regulated industry, medical device experience preferred- 3+ years management experience- Knowledge of medical device regulations, pertinent standards and ... - Apr 26
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