Process Engineering Mechanical Jobs in Indiana

Strong Project Management skills with experience in the use of Lean Six Sigma tools.

Conduct equipment process capability studies. Develop action plans to address deficiencies in equipment capabilities to better align with customer requirements.

Provide technical expertise to production management for equipment evaluation and troubleshooting problem areas.

Prepare and implement Installation and Operational Qualification (IQ/OQ) protocols for new equipment installation validation.

Oversee and manage the monthly project budget for the department.

Oversee and manage any assigned external facilities or maintenance contracts.

Must have experience for supervision or management of production team to support routine commercial operations.

Build basic document management system to support Good Engineering Practices at beginning and to be eventually evolved to GMP level.

Excellent in time management and problem solving.

Lead or participate the strategy development for process qualification and execution.

BS in Biotechnology areawith 12 years’ experience in the biological manufacturing industry, particularly in process of microbial fermentation, recovery and purification.

Must be conversant with US FDA requirements governingmanufacturing operations for biological drug substance.