Senior Engineering Leader, GMP Biotech Operations

Ossium Health; Indianapolis (IN); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Competitive salaries

Stock options

401(k) matching

Medical, dental and vision coverage

Four weeks of PTO annually

Employer paid life insurance

Gym membership reimbursements

Job summary

Ossium Health in Indianapolis is seeking an Associate Director of Engineering to lead the engineering team within our manufacturing operations. This role is critical for ensuring equipment and processes support high-quality production while maintaining compliance with regulatory standards.

The ideal candidate will possess a degree in engineering, extensive experience in the biotech sector, and proven leadership capabilities. The position offers competitive benefits, including stock options and a generous PTO policy.

Qualifications

• 8 years of experience in pharmaceutical or biotech manufacturing or 12 years in a regulated environment.
• 4 years managing engineers or technical staff.
• Strong knowledge of CGMP/CGTP requirements.

Responsibilities

• Lead and develop an engineering team.
• Own equipment lifecycle management.
• Ensure engineering compliance with CGMP/CGTP.

Skills

People management

Project management

CGMP/CGTP knowledge

Root cause analysis

Communication skills

Education

Bachelor’s degree in Engineering

Tools

Computerized maintenance management systems (CMMS)

Business intelligence tools

Job description

Ossium Health in Indianapolis is seeking an Associate Director of Engineering to lead the engineering team within our manufacturing operations. This role is critical for ensuring equipment and processes support high-quality production while maintaining compliance with regulatory standards.

The ideal candidate will possess a degree in engineering, extensive experience in the biotech sector, and proven leadership capabilities. The position offers competitive benefits, including stock options and a generous PTO policy.