Manufacturing Specialist-Process Engineer (Biotech)

Location: United States; Corporate Headquarters in Thousand Oaks, California, with conditions listed in New Albany, Ohio

Company

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

What you will do

• Own, revise, and approve manufacturing procedures and assess process performance through floor observation and data review.
• Identify and implement process improvements, including cost and cycle-time reduction initiatives.
• Support process monitoring, control limits, deviation assessments, and quarterly process-monitoring reports.
• Participate in technology transfers, new product introductions, process validation, and equipment or process modifications.
• Support non-conformance investigations, corrective actions, CAPA closure, root-cause analysis, and incident trend evaluation.
• Provide change-control assessments, training materials, technical documentation, and support during regulatory inspections.

Requirements

• Doctorate degree; or a master’s degree plus 2 years of relevant experience; or a bachelor’s degree plus 4 years; or an associate degree plus 8 years; or a high school diploma/GED plus 10 years.
• Experience must be in engineering, manufacturing, packaging, or quality within pharmaceutical, medical device, or biotechnology companies.
• Technical understanding of bioprocessing and manufacturing operations.
• Experience with process improvement, Lean principles, Kaizen, Six Sigma, operational excellence, and problem-solving techniques.
• Experience with GMP production operations, change control, regulatory interactions, data analysis, and control charting.
• Strong organizational, technical writing, presentation, verbal communication, and project management skills.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• Retirement and savings plan with company contributions.
• Annual bonus program, stock-based long-term incentives, and award-winning time-off plans.
• Career development opportunities and flexible work models where applicable.
• Sponsorship for this role is not guaranteed.