Process Validation Engineer III

Company: Yoh, A Day & Zimmermann Company
Location: Bedford
Posted on: April 10, 2021

Job Description:

Position location: Bedford, NH


The Process Validation Engineer III performs an array of well-defined validation/qualification activities in support of cGMP pharmaceutical/medical device contract manufacturing across multiple CLIENT --facilities. These PV activities include working with clients to define process control parameters and design protocols to test and verify process robustness. The role requires audit and inspection management support. In collaboration with validation management, assist internal project teams and external validation firms on validation/qualification initiatives and to ensure project schedules are met. Complies with the requirements of the Safety Program, including CLIENT --Health and Safety mandates and OSHA requirements. In carrying out duties, PV Engineer contributes and promotes a positive and equitable working environment emphasizing the CLIENT --Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.

JOB DUTIES

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• Author Process qualification/ verification validation plans; this includes the development of client specific process requirements and specifications drafts to execute process performance qualifications, process simulation media fill protocols. Also compile trace matrices, perform data analysis, draft validation protocol discrepancy reports and draft process validation summary reports
  
• Author and perform the technical review of deviations and planned deviations, change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), perform activities for lot release (assess deviations and process changes
  
• Participate in client and Regulatory Audits. Work on CAPA and Deviations with minimal but some oversight to achieve quality, timely results
  
• Assist with determining impact of change control on qualified process and aseptic operations.
  
• Work closely with other validation department personnel and cross-functionally with MTS, Manufacturing, Engineering, Critical Utilities, Quality Assurance, and project management to achieve all project deliverables.
  
• Assist management with mentoring and training of colleagues on policies and procedures including the requirements for validation. --Perform all functions associated with process validation support.
  
• Develop and recommend science-based solutions with a focus on continuous improvement and compliance.
  
• Perform risk assessment and mitigation steps to achieve validation requirements and ensure each process remains in a validated state of compliance by compiling and analyzing data for continued process verification.
  
• Coordinate and execute validation protocol activities with consistent and effective communication with affected departments; working autonomously while keeping the manager updated regularly.
  
• Work in a highly independent fashion, with minimal to no direction in the execution of duties, while keeping teammates and manager informed and providing guidance to other engineers as needed.
  
• Write process validation and process simulation media fill protocols and technical study approaches.
  
  
  EXPERIENCE
  
  
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  • Experience in pharmaceutical or biopharmaceutical environment in operations/engineering/manufacturing/quality environments.
    
  • Skilled in the development and execution of PPQ's. Review commissioning, qualification and validation related system lifecycle documentation (user requirements, functional and design specifications, commissioning and qualification protocols).
    
  • Combination of equipment qualification, process validation, or cleaning validation is acceptable; QA pharmaceutical experience also preferred.
    
  • Validation experience with the following is highly preferred: Thermal characterization, Vacuum physics, Heat and mass transfer, Formulation, Aseptic Filling and Lyophilization, Steam Sterilization, data analysis and statistics.
    
  • Engagement and knowhow with regulatory inspections and knowledgeable in current industry standards and regulatory trends as they pertain to Validation of pharmaceutical or biopharmaceutical processes.
    
    
    PROFESSIONAL SKILLS
    
    
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    • Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EMA) for validation of GMP facilities.
      
    • Possess strong knowledge of Process Performance Qualification /Validation practices, including applicable regulations.
      
    • Excellent technical writing, verbal communication and presentation skills.
      
    • Proficiency in Microsoft Office including Word, Excel, Power Point, Project
      
      
      EDUCATION
      
      
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      • Bachelor of Science degree in Chemical Engineering, Biochemistry, Biology or related scientific discipline required with a minimum of 6 years of Pharmaceutical industry experience or combination of work experience in Validation, QA, MFG, MTS, Process Development or Engineering.
        
        
        QUALITIES
        
        
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        • Organized individual who is accustomed to working in a result oriented-focused, dynamic CMO environment.
          
        • Professional and collaborative team player must have strong interpersonal skills.
          
        • Honesty, integrity, respect and courtesy with all colleagues.
          
        • Ability to inspire others to strive for excellence.
          
        • Self-motivated and able to meet goals with minimal supervision.
          
          
          PHYSICAL REQUIREMENTS & MENTAL DEMANDS
          
          
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          • Ability to lift 50 pounds
            
            
            Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.PandoLogic. Keywords: Quality Control / Quality Assurance Engineer, Location: Bedford, TX - 76095

Keywords: Yoh, A Day & Zimmermann Company, Bedford , Process Validation Engineer III, Engineering , Bedford, Texas