Job Description

Kymanox is hiring a Contract Quality Engineer to support our team at the Petersburg, VA site.



The Contract Quality Engineer will support the Quality Engineering team at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as Civica\xe2\x80\x99s new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications. Responsibilities of the position include establishing and maintaining quality systems and oversight to ensure the validation/qualification and operation of process, facility, equipment, and computer systems meet cGMP and Civica compliance requirements at the onset of building the facility leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.

The role supports the Manager of Quality Engineering through oversight and compliance support to Civica\xe2\x80\x99s biologic similar Insulin pre-filled injectable pen program to ensure FDA requirements are met.

Essential Duties and Responsibilities:

• Quality and compliance oversight of System and Product workstreams directly supporting biological products in Civica\xe2\x80\x99s pipeline. This includes:

• Combination product development activity oversight

• Pharmaceutical process validation in accordance with current regulations (e.g., 21 CFR 210, 211 and FDA Process Validation Guidance-2012)
• Device development and design controls in accordance with current regulations (e.g., 21 CFR 820 and ISO 13485)
• Provides Quality oversight of documentation and physical activities supporting systems and processes.
• Support and ensure compliance of product and process transfers, including validation, from and/or to other manufacturing sites.
• Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, and investigations.
• Participate or lead in quality risk analysis.
• Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
• Promote a quality mindset and quality excellence approach to all activities.
• Promote a safety mindset and focus on safety for all operations activities.

Basic Qualifications and Capabilities:

• A combination of education and experience, at a minimum holding a bachelor\xe2\x80\x99s degree in a scientific discipline and a minimum of 5 years of experience directly related to the Essential Duties and Responsibilities.
• Direct Device Master Record (DMR) management experience.
• Direct technical drawing review and approval experience.
• Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
• Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
• Ability to work autonomously and within established guidelines, procedures, and practices.
• Committed to delivering high quality results, working with others to overcome challenges, and focusing on what matters.
• Continuously looking for opportunities to learn, build skills and share knowledge with others.

Preferred Qualifications:

• Experience in facility, utilities and equipment qualification, computer and process validation, calibration and maintenance and data integrity.
• Experience and/or certification in statistical techniques.
• Experience across the product development and commercialization lifecycle including change management and associated implementation strategies.
• Technical expertise in combination product and medical devices.

Physical Demands and Work Environment:

This role will be expected to be on site for 80% of the work week, with exception of one day remote per week. In addition, the role will be required to be on site to perform Essential Duties and Responsibilities when physical activities are being performed on site.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.

The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.



About Kymanox:

Join Kymanox and 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\xe2\x80\x99s 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\xe2\x80\x99s 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. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC, and we have offices in Boston, Chicago, Philadelphia, and New Jersey.

Kymanox