Remote Senior Process Validation Engineer

Aldevron; Chicago (IL); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Medical/Dental/Vision Insurance

401(k)

Paid Time Off

Remote work arrangements

Job summary

Aldevron is seeking a Senior Engineer, Process Validation to lead and support validation projects enabling the commercialization of life-saving medicines. This role reports to the Process Validation Manager within the Technical Operations Department in Fargo, ND, and will be fully remote.

Responsibilities include validating sterile fill-finish processes, applying risk-based approaches, and collaborating with MSAT, manufacturing, QC, QA and RA.

Qualifications

• Bachelor or master degree in engineering and 5+ years of experience.
• Prior experience leading process development, engineering, and deliverables across all three stages of process validation in biologics/small and large molecules manufacturing, using statistical analysis, risk assessment, and process improvement tools.
• Knowledge of global regulatory requirements and cGMP regulations for pharmaceutical manufacturing operations and validation procedures and practices.
• Proficiency in technical writing with deviation investigations, root cause analysis, and risk assessments.
• Ability to travel 15% to site to support validation project executions, routine inspections, audits, and client visits.
• Previous experience in packaging and shipping validation of final product container closure configurations.
• Client‑facing experience in a CDMO environment.

Responsibilities

• Design, execute, and summarize deliverables across the three stages of process validation.
• Lead planning, execution, and lifecycle management of sterile fill‑finish validation strategies.
• Drive risk‑based approaches and apply statistical tools to evaluate process performance.
• Serve as technical SME for process validation with external clients and internal teams.
• Mentor junior validation associates in Process Validation and cGMP principles.

Skills

Process Validation

Risk assessment

Statistical analysis

Client-facing

DOE interpretation

Education

Bachelor's or Master's in Engineering

Tools

Statistical Software

Job description

Aldevron is seeking a Senior Engineer, Process Validation to lead and support validation projects enabling the commercialization of life-saving medicines. This role reports to the Process Validation Manager within the Technical Operations Department in Fargo, ND, and will be fully remote.

Responsibilities include validating sterile fill-finish processes, applying risk-based approaches, and collaborating with MSAT, manufacturing, QC, QA and RA.