Scientist - Biotech jobs in Indiana

• Develop and implement validation plans, protocols, and reports for equipment, processes, and systems.
  
• Generate and manage project plans, preventative maintenance coordination, and risk mitigation.
  
• Oversee validation projects from initiation to completion.
  
• Coordinate with cross-functional teams to align on project schedules, plans, and deliverables.
  
• Support overall engineering testing activities by developing, revising, and executing commissioning, validation, and SAT protocols.
  
• Provide ongoing support and technical expertise through validation execution and qualification activities.
  
• Conduct risk analyses and identify potential risks, recommending areas of improvement.
  
• Perform risk assessments to identify critical process parameters and develop mitigation strategies.
  
• Ensure all validation activities comply with FDA, EMA, and other relevant regulatory bodies.
  
• Additional responsibilities as required.
  

Requirements

• Bachelor's degree in related engineering discipline.
  
• 5 years of validation engineering experience in the pharmaceutical/life science industry.
  
• Experienced in paperless validation, preferably ValGenesis.
  
• Proven success in managing, reviewing, authoring, and approving full lifecycle technical documentation.
  
• Strong understanding of engineering specifications and requirements.
  
• Experienced generating and executing Validation activities on a range of equipment and systems.
  
• Proven success in project coordination/management responsibilities. Ability to effectively communicate and align team members, and schedule/develop project plans.
  
• Excellent technical writing skills.
  
• Strong understanding of industry regulations and requirements.
  
• Excellent communication and interpersonal skills.
  
• Strong attention to detail and commitment to quality and compliance.
  
• Strong problem solving and analytical skills.
  
• At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
  

Benefits