Specialist, Manufacturing – Production Process Owner (Biologics Manufacturing)

Location: Thousand Oaks, California, United States

Salary: USD 107,545.40–145,502.60 annually

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

• Support major deviation investigations from a Drug Product process perspective, including root cause analysis, human performance evaluations, CAPAs, and effectiveness monitoring.
• Initiate, revise, review, and approve controlled manufacturing documents in the electronic document management system.
• Support implementation of new processes, equipment, technologies, SOPs, batch records, training, validation, and automation configurations.
• Collaborate with Engineering, Quality, Process Development, Operations, and Capital teams to define requirements and achieve operational readiness.
• Analyze manufacturing performance data to identify trends and improve yield, reliability, compliance, and process robustness.
• Support process validation, change control, process parameter definition, control limits, and continuous improvement initiatives.

Requirements

• Doctorate degree; or a Master’s degree with 2 years of manufacturing experience; or a Bachelor’s degree with 4 years; or an Associate’s degree with 8 years; or a high school diploma/GED with 10 years of manufacturing experience.
• Experience in manufacturing, preferably aseptic Drug Product or biologics manufacturing.
• Knowledge of process validation, deviation management, change control, and GMP requirements.
• Experience with root cause analysis and major deviations.
• Strong analytical, problem-solving, project coordination, communication, and cross-functional collaboration skills.
• Ability to use data visualization and analytics tools such as Spotfire, JMP, Excel, and Enterprise Data Lake.

Culture & Benefits

• Collaborative, innovative, science-based work environment focused on serving patients.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
• Retirement and savings plan with company contributions.
• Annual bonus program and stock-based long-term incentives, subject to eligibility.
• Paid time-off plans and career development opportunities.
• Flexible work models where applicable to the role.

Hiring process

• No application deadline; applications remain open until a sufficient number of applications are received or a candidate is selected.
• Visa sponsorship is not guaranteed.