Kelly Services is currently seeking Validation Engineer for one of our top clients in Leesburg, VA.
JOB TITLE: Validation Engineer
INDUSTRY: Medical Device
WORK LOCATION: Leesburg, VA
DURATION: 6 Months (Temporary / Contract)
Implementing the validation strategy, based on Corporate procedures and regulatory requirements.
Supporting validation activities by providing guidance and expertise to authors of validation documentation and executors of validation protocols at the local site.
Reviewing and approving of validation documentation to ensure compliance with regulations and validation best practices.
Will work within the QA Shared Services Validation Team, responsible for validation related activities, including, but not limited to the following:
• Having knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local procedures as they relate to validation activities.
• Participating within Corporate Validation Team to develop and revise Validation Procedures and Templates to ensure that Current Regulatory Compliance and Company Objectives are maintained.
• Participating on both Corporate and Local Validation Teams to discuss / give feedback and approve revisions to Validation Procedures.
• Representing validation at both internal and external audits.
• Ensuring that Validation Practitioners receive training/coaching to allow them to effectively support and/or perform validations for current and anticipated projects.
• Ensuring that appropriate Systems are in place to evaluate changes to Validated/Qualified Systems to ensure their continued validated/qualified state.
• Ensuring that appropriate Site Validation Listing is established and controlled as per Current Regulatory and Company Requirements.
• Reviewing and approving of Validation/Qualification Documentation.
• Working with Validation Consultants/Contractors as required ensuring that Validations are completed as per corporate and divisional procedures.
• Being the site responsible for at least 1 validation specialty and be the primary support for that specialty and site.
• North America
o Bachelor of Science, Engineering or related subject with 3 to 5 years of experience in validation, or
o Masters of Science, Engineering or related subject with 0 to 2 years of experience in validation
• Excellent communication skills and attention to detail.
• Have a good understanding of engineering and machine tool fundamentals.
• High level of PC skills.
• Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
• Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
• Must be willing to work as part of a multi-site team, be able to travel as part of the job
• Knowledge of Computer System Validation including GAMP 5 and 21 CFR part 11 requirements desirable.
• Working knowledge/experience of Risk Based Techniques i.e. FMEAs, FTAs etc.
• Have a good understanding of statistical techniques, in particular statistical sampling plans, Process Capability, Gauge R&Rs.
• Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
• Highly developed problem solving and strong analytical skills.
• Lean Six Sigma training a distinct advantage.
Kelly® puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly® as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly® to explore opportunities that suit your specific professional interests.
As a Kelly Services employee, you will have access to numerous perks, including:
- Exposure to a variety of career opportunities as a result of our expansive network of client companies
- Career guides, information and tools to help you successfully position yourself throughout every stage of your career
- Access to more than 3,000 online training courses through our Kelly Learning Center
- Weekly pay and service bonus plans
- Group-rate insurance options available immediately upon hire*
Let us help advance your career today.
Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity, and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct-hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
Apply on company website