Kelly Services is currently seeking Validation Specialist for one of our top clients in Jayuya, PR.
JOB TITLE: Validation Specialist
WORK LOCATION: Jayuya, PR
DURATION: 6 Months (Temporary/Contract)
Lead new and existing products change implementation review, from process evaluation through FDA approval and products launch. Execute all related activities to new products introduction and product changes and Change Control procedures. Assures that the Company complies with all internal and external standards and regulations.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Provide technical support to Manufacturing, Engineering and Quality areas for the manufacturing environment of parenteral solutions and medical devices. Manage all New Product introduction and Product Change Controls related activities with corporate and internal plant resources, to meet milestones and deadlines. Participate on the evaluation of customer requirements for New Products and provide suggestions for process/product improvements. Gets involved and/or lead company teams such as: New Products Team, Change Control Review Board, etc. Lead a functional team for special projects. Includes perform team meetings, track progress, action items and deliverables. Report results to management as required by supervisor. Evaluate, change, advise and train manufacturing operators, supervisors or managers for any new policy, procedure or practice related but not limited to material control, PRMS documentation, batch record documentation, material usage reporting and any other initiative. Implementation of manufacturing projects developing timelines and periodic meetings to report projects progress and implementation strategies in order to meet deadlines. Provides technical information concerning processing techniques, materials, properties, and process advantages and limitations which affect long range plant and product engineering planning. Assists and support in the trouble shoot of projects as required. Able to handle multiple tasks at the same time. Willing to work extra hours, any shift or Holidays (e.g. shutdowns, extraordinary events). Must be able to keep the work area in the cleanest and order conditions. Team worked oriented, active participation in Company teams when required. Determines work procedures, prepares work schedules, and expedites workflow. Review validation protocols and reports for the qualification of manufacturing process, equipment's and process changes as necessary. Implements changes and follow-up actions to ensure the effectiveness of the changes. Interface with other plants and Divisional groups when required. Coordinate and participate in experimental productions. Support manufacturing/quality functions (Documentation, Laboratories, Process, Engineering) in the preparation and development of new products process and batch release related to FOC / Protocols. Generate cost analysis for product development. Able to work with minimum supervision. Should be able to work with multiple projects and handle multiple tasks at the same time. Teamwork oriented. Communicate effectively at all Levels.
EDUCATION and/or EXPERIENCE
Bachelor's degree in Engineering, Natural Sciences or Bachelor's degree with manufacturing experience minimum of 5 years' experience in product development, change control, validations in Computer System Validation; Master degree or PhD with at least 2-3 years of experience will be equivalent.
Ability to discuss normally encountered technical or project management issues, both
verbally and in written form. Ability to work as a collaborative team member with good negotiations skill. Ability to solve routine design, engineering problems with assistance. Skills in MS Project/MS Excel and Word applications to do process analysis and technical reports. Knowledge of problem-solving and statistical techniques. Good interpersonal skills. Traveling is required.
Ability to read, analyzes, and interprets general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, internal or external audits. Fully bilingual (English and Spanish languages). Ability to communicate at any Plant level.
In PR Kelly Offers!
- 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
- *Holidays paid and Christmas bonus*
As a worker today, it's up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what's next is what we're all about. We know what's going on in the evolving world of work—just ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.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.
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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