Engineer I (Biotech Manufacturing)

Location: Thousand Oaks, California, United States; onsite manufacturing support

Company

hirify.global is a biotechnology company researching, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Support the operation, reliability, commissioning, validation, and maintenance of cGMP equipment and facilities.
• Lead or support capital projects, equipment verification, and risk-based validation activities.
• Coordinate engineering, automation, maintenance, instrumentation, manufacturing, project management, and quality assurance stakeholders.
• Ensure compliance with cGMP documentation, safety practices, FDA, OSHA, and EPA requirements.
• Drive Lean, Six Sigma, PDCA, and other continuous improvement initiatives to improve cost, safety, quality, and speed.
• Provide technical support for manufacturing and maintenance and defend equipment calibration, maintenance, and validation during regulatory inspections.

Requirements

• Master's degree; or bachelor's degree plus 2 years of engineering or manufacturing experience; or associate's degree plus 6 years; or high school diploma/GED plus 8 years.
• Bachelor's degree in engineering or another science-related field preferred.
• Experience with regulated environments and cGMP procedures for pharmaceutical or biotechnology production, facilities, clean utilities, instruments, and equipment.
• Experience with risk-based verification, validation protocol development and execution, and combination product or medical device quality systems verification.
• Knowledge of process equipment, cell culture, fermentation, purification, filling, and process automation infrastructure.
• Strong communication, technical writing, facilitation, collaboration, SOP development, and training skills.

Nice to have

• Knowledge of DeltaV, Rockwell, and Plant Information Systems.
• Seven or more years of relevant experience, including five or more years in operations or manufacturing.

Culture & Benefits

• Collaborative, innovative, science-based working environment.
• Retirement and savings plan with company contributions.
• Medical, dental, vision, life, disability, and flexible spending benefits.
• Annual bonus program, stock-based long-term incentives, and paid time off.
• Flexible work models where applicable to the role.