Senior Process Validation Engineer — Remote Life Sciences

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

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Job summary

Aldevron, a Danaher operating company, is seeking a Senior Engineer, Process Validation to lead validation programs from development through commercialization in Fargo, ND with remote options. You will coordinate sterile fill‑finish validation, risk-based assessments, and client interactions while ensuring cGMP compliance.

You will mentor junior staff and collaborate with MSAT, manufacturing, QC, QA, and RA teams to ensure robust validation deliverables and regulatory readiness.

Qualifications

• Bachelor’s or Master’s degree in engineering or related field.
• 5+ years of experience in leading process validation in biologics/small and large molecules manufacturing.
• Knowledge of global regulatory requirements and cGMP regulations.
• Proficiency in technical writing with deviation investigations and risk assessments.

Responsibilities

• Lead and support internal and external validation projects enabling commercialization of biologics.
• Manage sterile fill‑finish validation strategies, including aseptic processes and packaging validation.
• Apply risk-based approaches using pFMEA, risk ranking, and control charts; perform DOE interpretation.
• Serve as technical SME during client audits, regulatory inspections, and cross-functional reviews.
• Mentor junior validation staff in Process Validation and Quality by Design.

Skills

Process Validation

Biologics/SMO

Statistical analysis

Risk assessment

cGMP

Technical writing

Deviation investigations

Root cause analysis

Education

Bachelor’s or Master’s in Engineering

Tools

DOE

Statistical software

Job description

Aldevron, a Danaher operating company, is seeking a Senior Engineer, Process Validation to lead validation programs from development through commercialization in Fargo, ND with remote options. You will coordinate sterile fill‑finish validation, risk-based assessments, and client interactions while ensuring cGMP compliance.

You will mentor junior staff and collaborate with MSAT, manufacturing, QC, QA, and RA teams to ensure robust validation deliverables and regulatory readiness.