(Contract) CQV Engineer - Project Based
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.
The (Contract) CQV Engineer will have direct experience in Commissioning, Qualification or Validation. This contract role will support a client based in GA over a 3-month time period.
Responsibilities:
- Leading and executing a variety of technical projects and/or programs.
- Define, develop, and execute the validation lifecycle following GAMP5® principles – including requirement specifications and qualification protocols (e.g., URS, FRS, DDS, DR, IQ, OQ, PQ, TM) in support of Commissioning & Qualification (C&Q) activities.
- Collaborating with Engineering and Quality professionals.
- Commissioning and Qualification of GMP facilities, utilities, and equipment.
- Provide technical project leadership and contributions to CQV projects, including managing schedules, support staff, and project execution.
- Provide review and input on areas of subject matter expertise.
- Review and summarize data for presentation to quality and regulatory professionals.
Educational Background:
- The ideal candidate will have a bachelor’s degree in a science-related field such as Biomedical Engineering, Mechanical Engineering or Chemical Engineering.
Experience:
- 5+ years of experience in the Biotechnology, Pharmaceutical, and/or Medical Device industries working in one (1) or more of the following departments:
- Validation (preferred)
- Manufacturing
- Process Engineering, Technical Services, or Manufacturing Sciences
- Quality Control or Quality Assurance
- Process Development
- Must have experience in Life Science industry performing IOQ on automated equipment. Experience with device assembly equipment is preferred.
- Leading and executing a variety of technical projects and/or programs.
- Collaborating with highly skilled professionals.
- Commissioning, start-up, and qualification of GMP facilities, utilities, or equipment.
- Working with quality and regulatory professionals.
Desired Aptitude and Skill Set:
- Proven ability to develop validation strategy independently
- Detail-oriented
- Highly organized
- Managerial (i.e., “do things right”) or leadership (i.e., “do the right thing”) skills
- 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
- Seasoned soft skills
- Team player
- IT and technology savvy
- Understanding of FDA’s CGMPs (i.e., Quality Systems)
Travel:
Up to 10% travel is possible. Travel requirements to GA are: 1 five-day trip in November, 2 weeks straight before the holidays, and 2 weeks in January. Travel expenses are covered.
Compensation:
Hourly 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.