Global MSAT Principal Engineer - Process Transfer Validation

Evotec WD; Redmond (WA); On-site; USD 155,000 - 172,000; Full time

Benefits offered by this job

Discretionary annual bonus

401(k) with company match

Comprehensive benefits package

Job summary

Evotec WD is seeking a Principal Process Engineer – Global MSAT in Redmond, Washington. The role involves leading technology transfer for late-stage molecules, ensuring compliance through thorough documentation and risk assessments, and mentoring junior engineers.

Candidates should possess a Bachelor's degree with significant experience in biopharmaceutical manufacturing, particularly in cell culture processes. The position offers a competitive salary ranging from $155,000 to $172,000, along with a comprehensive benefits package including health insurance and flexible work options.

Qualifications

• 12+ years of relevant experience or 8+ years with an MS.
• Subject-matter expert in cell culture processes including upstream and downstream operations.
• Experience leading technology transfer and process validation activities.

Responsibilities

• Lead technology transfer of late-stage molecules and support commercial manufacturing.
• Conduct gap analysis and risk assessments for process validation.
• Develop templates for process validation strategies and agency submissions.

Skills

Cell culture biopharmaceutical manufacturing

Downstream processing

Technology transfer

Process validation

Statistical analysis

Manufacturing process lifecycle management

Regulatory CMC documents

Risk assessment tools (e.g., FMEA)

Education

Bachelor’s degree in engineering or related field

Master's degree (preferred)

Tools

DeltaV automation systems

Manufacturing Execution Systems

Job description

Evotec WD is seeking a Principal Process Engineer – Global MSAT in Redmond, Washington. The role involves leading technology transfer for late-stage molecules, ensuring compliance through thorough documentation and risk assessments, and mentoring junior engineers.

Candidates should possess a Bachelor's degree with significant experience in biopharmaceutical manufacturing, particularly in cell culture processes. The position offers a competitive salary ranging from $155,000 to $172,000, along with a comprehensive benefits package including health insurance and flexible work options.