(Contract) Validation Engineer – Manufacturing Equipment
Description
Is Kymanox the right fit for you?
You want to make a difference and have an impact…
You enjoy having an influence in your day-to-day work…
You are motivated by working alongside a team filled with
subject matter experts who will help you learn and grow…
You wake up every day and do what you do
… because patients deserve better.
If this sounds like you, you’ve come to the right place.
Kymanox is hiring a (Contract) Validaion Engineer to join our team. NC based candidates preferred to support a 3-4 month engagement.
Responsibilities:
- Define, develop, and execute validation lifecycle documents following GAMP5® principles – including requirement specifications and qualification protocols (e.g., URS, SRA, IQ, OQ, PQ, TM) in support of Commissioning & Qualification (C&Q) activities. Experience validating cleanrooms and fill/finish manufacturing equipment preferred.
- Participates in and supports a matrixed team environment with organization and detail-oriented initiatives.
- Reviews technically complex documentation to ensure compliance with relevant standards and regulations.
- Follows policies and standard operating procedures to support client projects.
- Completes assigned training requirements.
Educational Background:
The candidate will have a Bachelor’s degree in a science-related field such as Biomedical Engineering, Mechanical Engineering or Chemical Engineering.
.
Experience:
The ideal candidate will have 3+ years of experience in the Biotechnology, Pharmaceutical, and/or Medical Device industries working in one (1) or more of the following departments:
- Validation
- Manufacturing
- Process Engineering, Technical Services, or Manufacturing Sciences
- Quality Control, Quality Assurance, or Regulatory Affairs
- Process Development
Desired Aptitude and Skill Set:
- Proven ability to develop validation strategy and documentation independently
- Detail-oriented
- Highly organized
- Excellent written and oral English communication skills
- Understanding of own limitations
- Fast learner
- Ability to motivate self and others
- High energy level
- Excellent problem-solving skills
- Team player
- IT and technology savvy
- Understanding of FDA’s CGMPs (i.e., Quality Systems)
Travel:
25-50% travel to Concord, NC
Compensation:
Pay rate is commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions.
About Kymanox:
Join Kymanox – 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. 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.
To learn more about our company, please visit our website: Life Science Solutions | Kymanox
Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.