GMP CSV Automation Engineer

Initial Therapeutics, Inc.; Lebanon (IN); On-site; USD 66,000 - 171,600; Full time

Benefits offered by this job

Company bonus

401(k)

Vacation

Medical, dental, and vision insurance

Life and disability insurance

Job summary

Initial Therapeutics, Inc. is seeking an Automation Engineer to support the new Lilly Medicines Foundry in Lebanon, IN. The role involves automation support, validation testing, and compliance with regulatory standards. Ideal candidates have a B.S. in Engineering and experience in FDA-regulated environments.

The position offers a salary range of $66,000 - $171,600 and comprehensive benefits including a company bonus, 401(k), medical, dental, vision insurance, and paid time off.

Qualifications

• Minimum 2 years of experience in FDA-regulated environments.
• Experience with design, development, commissioning, or qualification of computer systems.
• Knowledge of GMP, regulatory requirements, and computer system validation.

Responsibilities

• Perform risk assessments for computerized systems.
• Develop and execute validation protocols for computerized systems.
• Ensure compliance with regulatory requirements and industry standards.

Skills

Process control validation testing

Computer system validation

Risk assessment

Strong problem-solving skills

Communication skills

Education

B.S. in Engineering or related degree

Tools

SCADA

DCS

MES

LIMS

Job description

Initial Therapeutics, Inc. is seeking an Automation Engineer to support the new Lilly Medicines Foundry in Lebanon, IN. The role involves automation support, validation testing, and compliance with regulatory standards. Ideal candidates have a B.S. in Engineering and experience in FDA-regulated environments.

The position offers a salary range of $66,000 - $171,600 and comprehensive benefits including a company bonus, 401(k), medical, dental, vision insurance, and paid time off.