Senior Drug Product MSAT Engineer

About the role

The Drug Product Manufacturing Science and Technology (MSAT) Engineer supports equipment selection, management of equipment qualification, and process validation activities. They also solve issues during technology transfer and cGMP start-up for internal or external manufacturing sites, provide on-the-floor support during operations, review process data to ensure operational consistency, and support investigations.

Responsibilities

• Supports equipment selection, management of equipment qualification, and process validation activities
• Acts as the technical lead for technology transfer of drug product manufacturing processes to manufacturing facilities
• Tracks and reports project milestones related to raw material/component procurement, equipment readiness, process transfer, manufacturing document creation, etc.
• Reviews and approves cGMP batch documentation (master batch records, component specifications, validation protocols, material specifications, etc.) required to support cGMP production at manufacturing facilities
• Assists with investigation and root cause determination and CAPA identification and implementation for manufacturing deviations
• Trends process performance and collaborates with internal and external teams to establish/improve process performance, process capability to ensure process is operating within intended process control strategy
• Authors technical reports/protocols in support of cGMP activities
• Supports development of sampling plans for cGMP batches related to process characterization, process qualification, lot release, stability etc.
• Supports the drafting of regulatory filings and responds to regulatory information requests

Requirements

• Bachelor's degree in Engineering; chemical engineering or biomedical engineering preferred
• 5+ years of relevant experience

Qualifications

BS in Engineering; chemical engineering or biomedical engineering preferred and 5+ years of relevant experience

Skills

Not specified

Benefits

Not specified

Pay

$67,400.00 - $128,700.00 annually

Schedule

Monday-Friday, 8am-4:30pm

25-50% travel domestic & occasionally international