Quick Overview
Seniority
Mid Senior
Work mode
On Site
Location
Bloomington, IN, United States
Posted
Yesterday
Job Description
Job role: Senior CQV Engineer
Location: Bloomington, IN (Onsite)
Requirements:
- Approximately 5+ years of experience supporting engineering, commissioning, qualification, validation, or equipment implementation within pharmaceutical, biotechnology, medical device, or another regulated manufacturing environment.
- Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline preferred, or equivalent relevant industry experience.
- Strong understanding of manufacturing equipment and equipment systems, including how equipment is designed, installed, operated, tested, and maintained.
- Demonstrated project engineering experience supporting equipment installation, startup, commissioning, or qualification.
- Experience working directly with equipment vendors, engineering teams, manufacturing personnel, and Quality.
- Working knowledge of CQV lifecycle activities, including FAT, SAT, commissioning, IQ, OQ, and PQ.
- Ability to read and interpret engineering drawings, equipment specifications, P&IDs, and technical documentation.
- Ability to author clear and technically accurate engineering and CQV documentation.
- Strong troubleshooting and problem-solving skills with the ability to identify and resolve equipment-related issues.
- Understanding of cGMP requirements and Good Documentation Practices.
- Strong communication, organizational, and project coordination skills.
- Ability to work independently while effectively collaborating within multidisciplinary project teams.
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