Specialist Manufacturing – Cleaning Validation

Location: US - California - Thousand Oaks; on-site work required. Availability to work day, swing, graveyard, weekend, and holiday shifts may be required by the production schedule.

Salary: $107,545.40–$145,502.60 annual base salary.

Company

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

What you will do

• Own equipment cleanability assessments and cleaning and sterilization validation requirements for new product introductions and existing products, including MAC/MAR assessments.
• Lead complex cross-functional projects with Manufacturing, Quality, Engineering, Process Development, and Supply Chain from planning through implementation.
• Provide technical support for GMP manufacturing, including on-floor troubleshooting, function testing, validation execution, deviation investigations, and corrective and preventive actions.
• Develop, execute, review, and approve validation strategies, protocols, reports, acceptance limits, sampling plans, and characterization studies.
• Support commissioning, qualification, audits, inspections, routine monitoring, change controls, and maintenance of the validated state.
• Analyze validation data, identify trends, represent Cleaning Validation during regulatory inspections, and coach colleagues.

Requirements

• Doctorate degree; or a master's degree with 2 years, bachelor's degree with 4 years, associate's degree with 8 years, or high school diploma/GED with 10 years of experience in Validation, Engineering, GMP Manufacturing, or Process Development.
• Expertise in equipment cleanability, equipment qualification, cleaning and sterilization validation, and MAC/MAR in a biologics facility.
• Experience developing and approving validation strategies, protocols, reports, acceptance limits, and sampling plans.
• Experience supporting GMP manufacturing, technical troubleshooting, quality investigations, regulatory submissions, change controls, CAPAs, and deviations.
• Knowledge of EudraLex Annex 15, FDA Title 21 CFR Parts 210 and 211, ASTM E2500, and ICH Q7.
• Strong technical writing, presentation, mathematical, data analysis, and Microsoft Excel skills.

Culture & Benefits

• Collaborative, innovative, science-based work environment focused on serving patients.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Award-winning time-off plans and career development opportunities.
• Sponsorship for this role is not guaranteed.