Kelly Services is seeking an Senior Validation Engineer for our well-known client in the Pharmaceutical industry in Grand Castle NY. This is a 6-month contract to hire role.
Title: Senior Validation Engineer
Location: Grand Island NY
Duration: 6 months – Contract to Hire
Key Objectives of the role:
- Supports the manufacturing process owners and other functional area managers as a Quality Management System subject matter expert
- Leads complex cross-functional quality investigations in a variety of subject matter area to determine root cause and corrective actions
- Develops improvements to the Quality Management System to enhance compliance with regulatory requirements
- Leads teams to investigate deviations and non-conformances identifying root cause, corrective/preventive actions, and effectiveness of actions taken
- Initiates, reviews and approves changes to procedures and processes to ensure compliance with required standards
- Contributes expert process knowledge for product and process design and validation teams
- Works directly with customers (internal,external, suppliers) on complex critical to quality issues
- Leads cross-functional team projects (R&D, Mfg, Vendors, etc). Examples: support new product introduction projects or quality improvement projects
- Performs complex statistical analysis to analyze trends, and supports site-level KPI metrics (e.g. yield improvements, CAPA, complaint, and scrap reduction)
Minimum Qualifications (must have):
- Bachelor's degree in Engineering or Science Discipline.
- Minimum 5 years' experience within the Medical Device or Pharmaceutical Industry supporting the manufacture of Regulated Product
- Advanced knowledge of Quality Engineering principles and practices in a FDA Regulated Environment
- Quality standards (e.g., 21 CFR Part 820, ISO 13485)
- Quality tools (e.g. FMEA, Risk Analysis, Root Cause Analysis)
- Computer Systems (e.g. Trackwise, AGILE, SAP)
- Proficient in team building and leading product quality investigations
- Technical report documentation and authoring procedures
- Resolution of Customer Complaints and CAPA's
As a Kelly employee, you'll have access to premier perks, including:
- Kelly-sponsored Affordable Care Act health care coverage available to eligible employees
- Group insurance options
- Service bonus plan
- Holiday pay plan
- Weekly electronic pay options
- Online training campus that provides more than 3,000 free courses to help improve and develop skills
- Outstanding online employee community
- Transportation Spending Accounts
- Offered and coordinated by Enroll VB. These plans are not sponsored by Kelly Services.
APPLY NOW !!!!!
Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.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 (plus, did we mention we provide a ton of benefits). 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.]] 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.
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