Senior Process Validation Engineer - Remote

Regulatory Jobs; United States; Remote; USD 100,000 - 130,000; Full time

Benefits offered by this job

Remote work

Medical insurance

Dental insurance

401(k)

Job summary

Aldevron, a Danaher operating company, seeks a Senior Engineer, Process Validation to lead and support validation projects that enable commercialization of vital life-saving medicines. This role reports to the Process Validation Manager and is part of the Technical Operations Department in Fargo, ND with a fully remote option.

In this role you will design, execute and summarize deliverables across the three stages of process validation, spanning starting materials, drug substance, and drug

Qualifications

• Lead process development and validation across three stages for biologics/small and large molecules.
• Knowledge of global regulatory requirements and cGMP for pharma manufacturing.
• Proficient technical writing, deviation investigations, root cause analysis, and risk assessment.

Responsibilities

• Design, execute, and summarize validation deliverables across all stages.
• Lead sterile fill-finish validation strategies and qualification programs.
• Apply risk-based approaches and statistical tools to evaluate process performance.
• Serve as technical SME for process validation with internal teams and clients.
• Mentor junior validation associates in cGMP and Quality by Design.

Skills

Process validation

Statistical analysis

Risk assessment

Quality by Design

Regulatory knowledge

Education

Bachelor or Master in Engineering

Tools

DOE

Control charts

FMEA (pFMEA)

cGMP

Job description

Aldevron, a Danaher operating company, seeks a Senior Engineer, Process Validation to lead and support validation projects that enable commercialization of vital life-saving medicines. This role reports to the Process Validation Manager and is part of the Technical Operations Department in Fargo, ND with a fully remote option.

In this role you will design, execute and summarize deliverables across the three stages of process validation, spanning starting materials, drug substance, and drug