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Validation Engineer - 18-27425
Ref No.: 18-27425
Location: Moncks Corner, South Carolina
Position Type:Contract
Shift:First
Shift Comments:Start Day of Week Monday
Hours per Day 8
Hours per Week 40
Job Category:Engineering
Benefits:401K, Dental Insurance, Life Insurance, Medical Insurance, Vision Insurance
Hiring a Contract Validation Engineer
Duration:  7+ Months
Client Location:  Moncks Corner, SC
Work Schedule:  40 Hours Weekly
Pay Rate:  $30.00 Hourly
Benefits: ACA Compliant Medical Insurance

Ensures compliance through latex process validation conformance. Facilitate the corrective action and failure analysis process. Process delineation studies, design of experiments (DOE), validation remediation and statistical analysis. Support internal documentation requirements.

MAJOR DUTIES AND RESPONSIBILITIES
  • Responsible for the execution or review of required validation activities supporting BDI initiatives.
  • Validate current and new products and processes.
  • Perform validation remediation as required.
  • Provide periodic updates of assigned validations and communicate identified roadblocks to QA/Ops Manager.
  • Participate in site validation strategy.
  • Provide input to site MVP and applicable project MVP.
  • Developes, updates and maintains site validation procedures and related records
  • Perform data integrity verification on assigned validation documents
  • Review and approve assigned validation documents as the QA engineer role
  • Assess operational control via audits and SPC techniques.
  • Identify causal relationships between observed failures, complaints and current manufacturing techniques. Product analysis and process evaluations are required to fulfill this requirement.
  • Draft appropriate documents to support the Quality systems. Support the document control and project management systems.
  • Support drawing control systems regarding their quality requirements.
  • Perform all duties required for compliance with validation- related corporate systems.
  • Make decisions on product/process quality based on evaluations.
  • Quality standards development.
  • Other duties as assigned by Supervisor.
EXPERIENCE / EDUCATION/TRAINING/SKILL REQUIREMENTS
To perform this job successfully, an individual must be able to perform each essential job duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
  • B.S. in Engineering field or equivalent
  • Basic knowledge of statistics and quality engineering techniques.
  • Experienced in validations, including but not limited to product, process, equipment, test methods, DOE, cleaning and software validations
  • Good technical writing skills for protocol generation.
  • Attention to detail
  • Good communication skills.
  • Experience in process improvements and automation.
  • Five years of process development and/or Quality technology experience.
  • Ability to work with and motivate personnel.
PHYSICAL DEMANDS AND WORK REQUIREMENTS
  • While performing the duties of this job, the employee is frequently required to stand; walk; use hands or arms (to finger, handle or feel objects, tools, or controls). The employee is occasionally required to sit; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and talk or hear.
  • The noise level in the work environment is normally quiet to moderate.
  • 100% of day spent indoors.
To Apply for immediate consideration please send resume to Louis Moliterno at Louis.Moliterno@onboardusa.com and reference job # 18-27425 in the Subject Line and indicate the best times to contact you (please include nights and weekends if needed).
 
**Candidates must complete background and drug screenings before starting any assignment.
 
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC.
 
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.