Job Description

Reference # : 17-06462Title : Automation Engineer I
Location : Rocky Mount, NC
Experience Level : Start Date / End Date : 08/07/2017 / 02/06/2018
Description
Sterilization Validation Engineer

Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for an Validation Engineer I for our client in Rocky Mount, NC.

Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world.

JOB DESCRIPTION:
The Sterilization Engineer will be responsible for ensuring that the sterilization validation activities associated with the porous load steam sterilizers supporting the Aseptic Manufacturing Facility are in compliance with Quality System requirements and recognized international standards. An emphasis will be placed on cycle development and performance qualification.

DUTIES AND RESPONSIBILITIES:
  • Autoclave load configuration design, cycle development and performance qualification.
  • Develop sound scientific rationale/strategy for validation of new or modified cGMP equipment and processes.
  • Ensure all aspects of Sterilization Validation adhere to required policies and procedures, including safety and training.
  • Writing and execution/coordination of sterilization protocol testing.
  • Coordinate testing of qualification activities.
  • Compile and report on relevant validation data and generate summary reports to document the results of the validation studies.
  • Aides in troubleshooting/impact assessment for atypical conditions during sterilization runs/validations.
  • Experience in root cause analysis.
  • Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations.
EDUCATION AND EXPERIENCE REQUIRED:
  • BS degree in a technical discipline
  • 0-2 years relevant experience
Sterilization Validation Engineer
  • Strong process understanding of moist heat, porous load sterilization and proficiency in use of the Kaye Validator.
  • Autoclave thermal mapping experience is essential.
  • Other commissioning experience is an advantage.
  • Possess strong project management, organizational, analytical, computer, writing and communication skills.
  • Knowledge of aseptic processing highly desired.
  • Knowledge of cGMP regulations and latest validation guidelines.
  • Able to handle multiple priorities in a fast-paced environment.
  • Able to work extended/odd hours around manufacturing schedule required.
  • Candidate must be able to Lift and carry light loads as necessary in conducting testing, sitting, standing, walking, weekend or long hours based on testing schedule, wear proper gowning and PPE in manufacturing areas as required to meeting GMP and OSHA requirements.
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • TransitChek Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
Interested in applying? Contact Karyn Suayan, at (201) 283.9627 or you may send your updated CV to Karyn.Suayan@eclaro.com now.
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Application Instructions

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