Kelly Services is currently seeking for Validations Specialists (various Positions) for one of our top clients in Jayuya, PR
Full Time Exempt Position $34.50
Performs, coordinates, and exercises functional authority for planning, organization, control, integration, and completion of engineering maintenance and process upgrade tasks within area of assigned responsibility. Use project management tools to achieve cost reduction results per the strategic plan on every budget process.
- Coordinates activities concerned with technical developments, scheduling, and resolving engineering design and test problems.
- Directs integration of technical activities and products.
- Evaluates and approves design changes, specifications, and drawing releases.
- Controls expenditures within limitations of project budget.
- Prepares interim and completion project reports.
- Assists, trouble shoots, give technical support to all assigned equipment and personnel.
- Develops, implements systems or projects, procedures and policies to assure the compliance with cGMP's, Safety and FDA regulations.
- Creates, reviews and implements changes to specifications and SOP's.
- Audits all areas under responsibility assuring the compliance, cGMP's, specifications, and procedures.
- Supports and assists in the trouble shoot of projects and equipment as required. Lead validations process.
- Completes all documentation and reports on a timely basis as required (daily, weekly, monthly and annually)
Directly supervises employees in the Technical Area. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Qualifications & Required skills include:
- BS in Engineering Mechanical or Electrical (other degrees accepted provided the individual has relevant experience in validations)
- State Engineering License Preferred
- Minimum of 3 years validation experience. At least 5 years of experience (preferred) and demonstrated performance within a GMP regulated environment within the pharmaceutical or medical devices industry (FDA Regulated environment)
- Ability to read, analyse, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to write reports, business correspondence, and procedure manuals.
- Able to communicate effectively at all Plant Levels. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Fully bilingual (English and Spanish languages).
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations and mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
- Keep and develop strong working team, manufacturing maintenance environment.
- Good and strong supervisions skills.
- Able to work with many projects and handle multiple tasks at the same time. Team worked oriented.
- Request and order all materials required on a timely basis to ensure an efficient performance of the department.
- Able to keep the work area in the cleanest and order conditions.
- Willing to work at any shift when its required; extra hours, any shift or Holidays (eg. shutdowns, extraordinary events).
- Willing to travel.
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*
* Must comply with minimum established requirements to qualify.
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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