Commissioning Qualification Engineer

About the Role

We are hiring experienced and motivated Commissioning and Qualification Engineers. Engineers will be responsible for developing commissioning and qualification protocols for a variety of utilities, facilities, and equipment in the pharmaceutical, medical device, and biotech industries. Successful candidates will possess expertise in KNEAT validation processes and methodologies, with experience integrating KNEAT solutions in risk-based commissioning and qualification strategies.

Responsibilities

• Develop commissioning and qualification protocols using KNEAT platforms for a diverse range of utilities, facilities, and equipment in the life science industry.
  
• Collaborate with cross-functional teams to integrate KNEAT solutions.
  
• Identify and assess risks associated with commissioning and qualification activities, and develop mitigation strategies.
  
• Generate comprehensive documentation, including protocols, reports, and validation documentation.
  
• Maintain accurate and organized records of all commissioning and qualification activities.
  
• Identify opportunities for process improvements and contribute to the development of best practices.
  
• Provide remote technical support during commissioning and qualification activities.
  
• Provide regular project updates and reports to key stakeholders, highlighting progress, challenges, and solutions.
  
• Work efficiently in a remote setting, effectively communicating and collaborating with team members and clients across different time zones.
  
• Ensure compliance with industry standards and regulations.
  
• Additional responsibilities as required.
  
  
  

Requirements

Qualifications

• Bachelor's Degree in related engineering discipline.
  
• 3-5+ years of commissioning and qualification engineering experience in the pharmaceutical, biotech, and medical device industries.
  
  

• Proven experience and knowledge of KNEAT systems and processes, and paperless commissioning and qualification.
  
• Demonstrated expertise in risk-based commissioning and qualification approaches and methodologies.
  
• Strong understanding of regulatory guidelines and compliance.
  
• Excellent technical writing skills.
  
• Excellent communication and collaboration skills in a remote work environment.
  
• Ability to manage multiple projects simultaneously and meet deadlines.
  
• Excellent problem-solving skills and attention to detail.