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Sr Quality Engineer / Validation Specialist

Randstad Engineering North Chicago, IL

  • Expired: over a month ago. Applications are no longer accepted.
Job Description
job summary:

A Sr Quality Engineer / Validation Specialist is needed for a research-driven biopharmaceutical company in the North Chicago, IL area. The primary responsibility for the Sr Quality Engineer / Validation Specialist is the planning and overall approval of validation tasks. Under the direction of the QA/Validation Section Manager, will participate in the implementation of the Validation quality program, but s/he will be expected to independently manage 5+ key projects simultaneously.

 
location: North Chicago, Illinois
job type: Contract
salary: $44.19 - 61.77 per hour
work hours: 8am to 5pm
education: Bachelors
 
responsibilities:
  • Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements
  • Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility
  • Executes tasks as required to implement the Validation Master Plan and maintain in a validated state the equipment, utilities, facilities, automated process controllers (APC), information systems, cleaning processes, manufacturing processes, C&Q activities to demonstrate that product will perform consistently as intended
  • Ensures investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system (Track Wise) where required by policy
  • Participates with plant and external engineering resources on new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation
  • May supervise contract validation resources in the timely completion of activities in his/her area of responsibility
  • May lead, author, or review investigations and implementation of preventive and corrective action

Qualifications:

  • Bachelor's Degree Required (preferably in Biology, Chemistry or Engineering)
  • 6+ years of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred
  • strong verbal and written communication skills
  • Solid problem solving and analytical skills
  • Solid interpersonal skills, including ability to negotiate/influence without authority
  • Ability to supervise junior or contract team members (prior supervisory experience preferred)
  • Ability to manage complex projects and multiple projects (5+) simultaneously
  • Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred

#LI-NM1

 
qualifications:
  • Experience level: Experienced
  • Minimum 6 years of experience
  • Education: Bachelors (required)
 
skills:
  • Validation
  • Quality
  • Manufacturing

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Randstad Engineering

Address

North Chicago, IL
60064 USA

Industry

Manufacturing

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