Commissioning & Qualification Validation (CQV) Engineer

  • Job Reference: 00001898-1
  • Date Posted: 1 January 2022
  • Company: GMP Pros
  • Website: http://texasjobs.jobboard.com/
  • Location: Omaha, Nebraska
  • Salary: On Application
  • Sector: Pharmaceutical/Biotechnology
  • Job Type: Permanent

Job Description

***THIS POSITION REQUIRES PHARMACEUTICAL, ANIMAL HEALTH, OR MEDICAL DEVICE INDUSTRY EXPERIENCE.  PLEASE DO NOT APPLY IF YOU DO NOT HAVE EXPERIENCE IN THESE INDUSTRIES. ****


Be part of an exciting start-up that supports the world's leading pharmaceutical and animal health companies.  Attain the best of both worlds, gain experience working for a global pharma company while enjoying the flexibility, energy, and personalized attention that can only be found working for a small company. 

We offer Flexible Time Off, a 10% Company-paid 401k Contribution (no requirement to match/immediate vesting), a $10,400 Benefits AllowancePerformance Coaching, and Training, Growth & Development. 

Are you a proactive doer? 

Do you try to find a better way for everything because that is the way it should be? 

Do you thrive in organized chaos and high-pressure situations? 

Do you quickly become an expert in any subject matter you are working in? 

Can you stay motivated and help motivate others in the face of adversity and change? 

Do you need variety and change to keep from getting bored? 

Do you feel beat down by corporate bureaucracy?  

What does it mean to be a Validation/Qualification Engineer with GMP Pros? The Essential Duties: 

  • Responsible for the periodic trending of process capability data to ensure compliance with FDA standards.  
  • Develop, implement, and maintain a continuous verification program to include periodic trending of process capability data including all necessary procedures.  
  • Write and execute IQ, OQ, and PQ protocols and summary reports for the facilities/utilities, manufacturing, and packaging areas as needed.  
  • Write and execute PV protocols and summary reports for product reformulations and New Product Introductions (NPIs).  
  • Participates in Validation SOP development and the ongoing maintenance of the validated status of GXP systems.  
  • Monitors validation criteria and assures compliance with written validation standards.  
  • Maintain up to date knowledge of validation requirements, practices, and procedures and instruct other members of the validation working party.  
  • Leads and ensures accountability to the site's Product Lifecycle Management governance process.  
  • Support site during internal audits as required.  
  • Comply with all local, state and federal EHS laws and regulations, and all Global EHS requirements. 
  • Responsible for the development, planning, and implementation of Qualification and commissioning for the manufacturing, packaging, facilities, computer, and or cleaning Equipment/ processes (hereafter collectively referred to as GMP systems/ Systems')  
  • Layout the strategy of Validation Approach for Qualification and Commission of GMP systems. From either but not limited to Prospective Validation, Concurrent Validation and Retrospective Validation depending on System requirements. 
  • Assist the governing team of IT infrastructure in establishing eCompliance and Data Integrity for the GMP or Non-GMP utilized computerized/Non-computerized/ Documentation/ Processes/Automation and analytical Process.  
  • Experience in Development of Validation life cycle Documentation to assurance that system and processes shall be in qualified state and consistently perform with reproducibility per Predetermined Specification/Requirements the below are the Validation lifecycle attributed that shall be achieved but not limited to the following. 
    • Pre-requisites for Validation 
    • Planning and Requirements 
    • Verification of Design 
    • Testing and Qualification 
    • Summary Reporting 
    • Maintaining the Validation Status 
    • Decommissioning of Validated Systems / Discontinuation of Product 
  • Write, review, and execute documentation to conduct all the Validation activities to support new or existing machinery and or product launches and maintain existing product validations or equipment Qualification/commissioning 
    • Validation Plan:  
    • Validation Summary Report:  
    • Protocol:  
    • Protocol Report. 
    • User Requirement  
    • Functional Specification (FS) 
    • Design Specification (DS)  
    • Execution of protocol:  
    • Standard Operating Procedures (SOPs)  
  • Necessitate and embody expertise in regulatory compliance, to determine requirement to Qualify/Commission and validate and discern appropriate level of the Validation for the process with respect to applicable Code of federal law e.g. CFR 21 part 11.  
  • Necessitate and embody expertise in regulatory compliance involves in the below but not limited to the following 
  • Monitoring of the Validation criteria and assurance of compliance. Prepare presentations for regulatory agencies like FDA or internal regulatory bodies regarding the Validation program and its status.  
  • Providing technical expertise and facilitate documentation assembly during regulatory audits. 
  • Establish Risk Assessment tools for GMP systems and Processes in compliance with the Code of federal law and FDA regulatory Authorities. 

Requirement:

A minimum of 5 years of Validation experience required.

Preferred Qualities and Traits:    

  • Must be driven to seek out new opportunities, ask questions and keep pursuing things when information is limited or not given at all.  
  • Corrective actions require new thoughts and ideas on existing equipment or problems. Approach things with a broad scope at first and engineer solutions.  
  • This is a tough position. You are in the trenches doing work a lot of others don't want to do. It's a great opportunity to grow and learn a wide variety of skills but if you let things get to you it will show in your attitude towards others. Real positivity within you will show and make others more willing to work with you and drop their guards.  
  • Must be able to quickly turn information received into concise verbiage on paper. Complete stories must be told of events that occurred and actions to be taken, but should not use fluff.   
  • ACTUALLY listen to everyone's input before forming your thoughts or replies. Operators and others in the plant have a wealth of process and product knowledge. Some are limited to their specific trade so it's your job to take their information to the next level and fit it into the bigger puzzle.  
  • In the fast moving and changing industry of OTC and Pharma, things will change continuously. Must be able to adapt to the changes and continue making progress.  
  • General knowledge of project timelines and cost is important, but don't let that limit you in the investigation and problem-solving phases.  
  • You won't always be right, and that's okay. There is a steep learning curve in this industry. Take in as much as possible and it will only benefit your future.  
  • Must be patient and focused while also having a continuous sense of urgency.  

Pre-Employment Requirements:   

  • Pass and maintain pre-employment background check.  
  • Subject to motor vehicle report review.  
  • Maintain valid driver's license and endorsements as required per position.  
  • Pass pre-employment physical, medical evaluation, and drug screen due to the safety sensitive nature of this position.  
  • Successfully complete and maintain any required safety certification and testing on an annual basis.