Sr. MSAT Engineer

Sr. MSAT Engineer GMP Technical Transfer & Documentation Support

Key Responsibilities

• Lead and support tech transfer documentation activities ensuring alignment between sending and receiving sites.
  
• Develop and author risk assessments mixing study protocols and Master Batch Records (MBRs) to support GMP manufacturing readiness.
  
• Collaborate with Process Development Manufacturing QA and MSAT SMEs to gather technical inputs and consolidate requirements.
  
• Apply risk-based science-driven decision-making to documentation and process assessments.
  
• Ensure all documents meet GMP data integrity and regulatory expectations including formatting approvals and version control.
  
• Support documentation packages required for equipment readiness batch execution and process understanding.
  
• Identify documentation gaps and recommend improvements to support a smooth technical transfer.
  
• Communicate progress risks and data needs to project leads and cross-functional partners.
  

Required Skills & Experience

• 510 years of MSAT Process Engineering Technical Transfer or Validation experience in GMP biotech or pharmaceutical manufacturing.
  
• Strong experience authoring or reviewing:
  

• Risk assessments (FMEA hazard analyses etc.)
  
• Study protocols (mixing studies process studies)
  
• MBRs / EBR content
  
• Technical reports and GMP documents
  

• Deep understanding of GMP data integrity and GDocP.
  
• Demonstrated experience supporting or leading technical transfer between internal teams or CDMOs.
  
• Ability to interpret process requirements equipment capability and manufacturing constraints.
  
• Excellent written communication skills with the ability to simplify complex technical concepts.
  

Preferred Qualifications

• Experience in biologics cell culture or aseptic manufacturing.
  
• Prior work in CDMO environments or external collaboration models.
  
• Knowledge of risk-based frameworks (ICH Q9) scale-up considerations and process characterization.
  

Compensation & Benefits

Equal Opportunity Employer

Pioneer GMP Consulting is an Equal Opportunity Employer. We do not discriminate based on race color religion sex sexual orientation gender identity national origin age disability veteran status or any other protected category under applicable law.