MST Engineer

• Drive overall process improvement projects providing GMP expertise focused on process optimization.
  
• Responsible for technology transfers.
  
• Manage the entire life cycle of equipment procurement including vendor evaluation FAT SAT as well as commissioning qualification and validation support.
  
• Perform facility fit and gap analysis.
  
• Author critical documentation including risk assessment OOS investigation and process issues.
  
• Develop and maintain GMP manufacturing documentation including product impact assessments.
  
• Define and provide user requirements for process equipment and associated drug product equipment.
  
• Facilitate and participate in project meetings decisions milestone mapping etc. effectively representing MSAT division.
  
• Collaborate closely with crossfunctional teams to ensure project success and timely deliverables.
  
• Present data and reports to internal and external teams.
• Additional responsibilities as required.
  

Requirements

• Bachelors degree in related engineering or scientific discipline.
  
• 5 years of experience in a Manufacturing Science & Technology role.
  
• Advanced experience in a GMP manufacturing environment.
  
• Ability to provide technical guidance and training within GMP manufacturing operations.
  
• Proven experience in technology transfers including the drafting and development of process documentation and analyses.
  
• Strong knowledge of regulatory requirements and industry standards.
  
• Experience and knowledge of pharmaceutical manufacturing product development.
  
• Strong analytical and problem solving skills.
  
• Excellent communication and interpersonal skills.
  
• Ability to build strong relationships across departments.
  
• Strong time management and organizational skills with the ability to coordinate multidepartmental tasks and deliverables.
  
• 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

• Medical Dental and Vision PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
  
• Insurance options for Employee Assistance Programs Basic Life Insurance Short/Long Term Disability and more.
  
• 401(k) and 401(k) matching
  
• PTO Sick Time and Paid Holidays
  
• Education Assistance
  
• Pet Insurance
  
• Discounted rate at Anytime Fitness
  
• Financial Perks and Discounts