Lead Aseptic Fill-Finish Process Engineer

Initial Therapeutics, Inc.; California (MO); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Market competitive base salary

Flexible paid time off

Remote work options

Job summary

Initial Therapeutics, Inc. is seeking a Sr. Fill–Finish Process Engineer to join our team in California. This role involves supporting the capital project buildout of a new fill–finish suite within a commercial pharmaceutical manufacturing facility.

The ideal candidate should possess strong experience in aseptic pharmaceutical manufacturing, along with expertise in formulation, sterilization processes, and GMP operations. This position includes collaboration with cross-functional teams to ensure compliance and continuous improvement in manufacturing processes.

Qualifications

• Typically 7 or more years of experience in GMP pharmaceutical or biotech manufacturing.
• Strong preference for sterile, aseptic, biologics, or vaccine fill–finish experience.
• Experience with commissioning and qualification documentation.

Responsibilities

• Support design and qualification of a new commercial fill–finish suite.
• Contribute to user requirement development and equipment specifications.
• Serve as subject matter expert for fill–finish operations.

Skills

Aseptic operations

Technical writing

Problem-solving

Multiple priorities management

Communication skills

Education

Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or related

Tools

Building management systems

Computerized maintenance management systems

KNEAT digital validation platform

Job description

Initial Therapeutics, Inc. is seeking a Sr. Fill–Finish Process Engineer to join our team in California. This role involves supporting the capital project buildout of a new fill–finish suite within a commercial pharmaceutical manufacturing facility.

The ideal candidate should possess strong experience in aseptic pharmaceutical manufacturing, along with expertise in formulation, sterilization processes, and GMP operations. This position includes collaboration with cross-functional teams to ensure compliance and continuous improvement in manufacturing processes.