Senior Engineer, Process Validation (Biologics)

Location: USA — Remote; the role is fully remote with up to 15% travel to sites for validation executions, inspections, audits, and client visits.

Annual salary: $100,000–$130,000, plus bonus or incentive pay.

Company

hirify.global’s Aldevron operating company provides CDMO services supporting the development and commercialization of genomic medicine and life-science products.

What you will do

• Design, execute, and summarize deliverables across all three stages of process validation for critical starting materials, drug substances, and drug products.
• Lead sterile fill-finish validation and qualification programs covering aseptic processes, sterile filtration, filling, visual inspection, container closure integrity, packaging, labeling, and shipping.
• Apply risk-based tools such as pFMEA, risk ranking, and criticality assessments.
• Use statistical methods including process capability analysis, trend analysis, control charts, and DOE interpretation to evaluate process performance.
• Act as a process validation subject-matter expert for clients, MSAT, manufacturing, QC, QA, and RA teams during audits, inspections, kaizens, and workshops.
• Mentor junior validation associates in process validation, cGMP regulations, and Quality by Design principles.

Requirements

• Bachelor’s or master’s degree in engineering and 5+ years of experience.
• Experience leading process development, engineering, and deliverables across all three stages of process validation in biologics or small- and large-molecule manufacturing.
• Knowledge of global pharmaceutical manufacturing regulations, cGMP requirements, and validation procedures.
• Proficiency in technical writing, deviation investigations, root cause analysis, risk assessments, and statistical analysis.
• Ability to work remotely from the USA and travel to sites up to 15%.

Nice to have

• Experience with packaging and shipping validation for final-product container closure configurations.
• Client-facing experience in a CDMO environment.

Culture & Benefits

• Flexible remote working arrangement for eligible roles.
• Paid time off.
• Medical, dental, and vision insurance.
• 401(k) benefits for eligible employees.
• Bonus or incentive pay eligibility.