(Contract) Senior Quality Engineer - Aseptic Manufacturing

Kymanox • TX

98d

About The Position

Kymanox is a life sciences professional services company dedicated to life sciences who has successfully delivered over 4000 projects across 20+ countries. Become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates, and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole. Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market.

Requirements

• Bachelor’s degree in a science-related or engineering discipline such as Biomedical Engineering, Mechanical Engineering, or Chemical Engineering.
• 7+ years’ experience working in development and/or manufacturing in the pharmaceutical, biotechnology, combination product, and/or medical device sectors.
• Demonstrated level of experience in the pharmaceutical, biotechnology, combination product, and/or medical device sectors.
• Familiarity with risk management tools and applications as well as data analysis tools and applications.
• Understanding of ISO 13485 and FDAs QMSR.

Nice To Haves

• Experience with pre-filled syringes, autoinjectors, co-packaged kits, other drug delivery platforms, and/or other combination product platforms.

Responsibilities

• Provides immediate project supervision and leadership.
• Participates in and supports a matrixed team environment with organization and detail-oriented initiatives.
• Reviews and/or approves technically complex documentation to ensure compliance with relevant standards and regulations.
• Completes gap assessments against industry regulations or standards.
• Participates in regulatory body inspections or remediation efforts.
• Follows policies or standard operating procedures to support internal or client projects.
• May support supply chain and vendor management strategy or compliance activities.
• Completes assigned training requirements (internal and external).
• Understands, authors and reviews both the Combination Product Design History File and Risk Management File.
• Understand and authors quality events such as CAPA, Deviations, OOS, Investigations and Complaints.
• May provide technical project management and meeting facilitation.

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 251-500 employees