MSAT Engineer - Bora Biologics - San Diego, CA

Pioneer GMP Consulting•San Diego, CA

1d•Hybrid

About The Position

Pioneer GMP Consulting is seeking a Sr. MSAT Engineer to support a technical transfer initiative for a biologics manufacturing client. This role blends MSAT expertise with high -level GMP technical writing, focusing on risk assessments, mixing study protocols, and Master Batch Records (MBRs). The ideal candidate brings strong process knowledge, hands -on tech transfer experience, and the ability to translate complex manufacturing requirements into clear, compliant documentation.

Requirements

5–10 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.

Nice To Haves

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.

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.