Lead Process Validation Engineer - Remote, Life Sciences

Danaher; Houston (TX); À distance; USD 100 000 - 130 000; Plein temps

Résumé du poste

Aldevron, a Danaher operating company, is seeking a Senior Engineer, Process Validation to lead and support validation projects enabling commercialization of new life-saving medicines. You will design, execute, and summarize deliverables across validation stages for biologics and small molecules, collaborating with MSAT, manufacturing, QC, QA and RA.

The role reports to the Process Validation Manager in the Technical Operations Department in Fargo, ND and is fully remote.

Qualifications

• Bachelor or master degree in engineering and 5+ years of experience.
• Experience leading process development and validation across stages.
• Knowledge of global regulatory requirements and cGMP regulations.
• Proficiency in technical writing with deviation investigations and risk assessments.

Responsabilités

• Design, execute, and summarize deliverables across three stages of process validation.
• Lead planning, execution, and lifecycle management of sterile fill-finish validation programs.
• Serve as technical SME for process validation with internal/external teams and audits.
• Mentor junior validation associates in cGMP and Quality by Design.

Connaissances

Process validation

Sterile fill-finish

Risk-based methods

Statistics

pFMEA

DOE interpretation

Technical writing

Formation

Bachelor or Master in engineering

Description du poste

Aldevron, a Danaher operating company, is seeking a Senior Engineer, Process Validation to lead and support validation projects enabling commercialization of new life-saving medicines. You will design, execute, and summarize deliverables across validation stages for biologics and small molecules, collaborating with MSAT, manufacturing, QC, QA and RA.

The role reports to the Process Validation Manager in the Technical Operations Department in Fargo, ND and is fully remote.