Senior Validation Engineering Specialist

Company: Nesco Resource
Location: Irvine
Posted on: November 22, 2021

Job Description:

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CA - Irvine Job DescriptionSenior Validation Engineering Specialist Position:



Position Summary:

Provide Validation and Engineering support to new and existing Pharmaceutical Manufacturing Operations.



Responsibilities: Essential Duties

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• Validates and revalidates new or modified products, equipment or systems. Establishes validation standards, develops and executes validation protocols, reports on findings and oversees resolution of compliance failures or deviation.
  
• Develops and maintains validation related documentation, which may include specifications, SOPs, work instructions or batch or testing records.
  
• Ensures processes, products, equipment or systems comply with all applicable external regulations or standards.
  
• May assist with new equipment purchases or upgrades to existing equipment.
  
• Functions as a subject matter expert, regularly interacts and works with senior management and uses advanced techniques, theories, and processes to complete work.
  
  The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
  
  
  
  General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.
  
  
  
  Expertise: Knowledge & Skills
  
  
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  • Requires advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, concepts. Determines best course of action.
    
  • Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of peers.
    
  • Judgement is required in resolving complex problems based on experience.
    
  • Contacts are primarily with department supervisors, leads, subordinates, and peers. Frequent contact with external contractors/vendors.
    
    
    
    Qualifications:
    
    
    
    Required:
    
    
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    • Bachelor's degree required, Master's degree preferred.
      
    • 08-10 years related experience required.
      
    • Regular and predictable attendance
      
    • Occasional business travel required
      
    • 10% Sign-On Bonus along with Relocation Assistance is available for this position!!
      
      
      
      Nesco Resource and affiliates (Lehigh G.I.T Inc, and Callos Resource, LLC) is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.
      Formats accepted: .doc / .docx / .pdf / .txt

Keywords: Nesco Resource, Irvine , Senior Validation Engineering Specialist, Engineering , Irvine, California