(Contract) Associate CQV Engineer

We are seeking a Contract Associate CQV Engineer to join our team. As a Contract Associate CQV Engineer, you will have direct experience in Commissioning, Qualification or Validation and will be responsible for authoring and executing qualification protocols, collaborating with stakeholders, and providing technical input during design reviews and risk assessments.

Requirements

• Bachelor's degree in a science-related field such as Biomedical Engineering, Mechanical Engineering or Chemical Engineering
• 0-2 years of hands-on CQV experience in pharmaceutical, biotechnology, and/or medical device industries
• Direct experience executing IOQ/PQ on automated equipment (filling lines, isolators, lyophilizers, device assembly equipment strongly preferred)
• Proven ability to author and execute qualification protocols independently
• Strong working knowledge of cGMP (21 CFR 210/211, Part 11, EU Annex 11), ASTM E2500, GAMP 5, and ISPE guidelines
• Experience with electronic documentation and quality management systems
• Excellent technical writing, organization, and communication skills

Benefits

• Hourly rate commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions
• Opportunity for career advancement
• Chance to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole