Remote Senior Process Validation Engineer

Aldevron; New York (NY); Sur place; USD 100 000 - 130 000; Plein temps

Avantages offerts par ce poste

Remote work options

Medical/dental/vision insurance

401(k)

Résumé du poste

Aldevron, a Danaher company, is seeking a Senior Engineer, Process Validation to lead and support validation programs that enable commercialization of vital medicines. This role reports to the Process Validation Manager in Technical Operations and is fully remote, based in Fargo, ND.

You will apply pFMEA, DOE, and statistical analysis to validate sterile fill–finish, containers, and packaging, mentor junior staff, and collaborate with MSAT, manufacturing, QC, QA and RA.

Qualifications

• Bachelor or Master’s degree in engineering; 5+ years of experience.
• 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.

Responsabilités

• Design, execute, and summarize deliverables across the three stages of process validation spanning starting materials to drug product.
• Lead validation strategies and qualification programs for aseptic manufacturing processes including sterile filling, visual inspection, and packaging validation.
• Drive risk-based approaches and apply statistical tools to evaluate process performance and capability.
• Serve as a technical SME for process validation with internal teams and during client audits/regulatory inspections.
• Mentor junior validation associates in Process Validation and cGMP principles.

Connaissances

Statistical analysis

Risk assessment

Quality by Design

Client-facing

Documentation

Formation

Bachelor or Master in Engineering

Outils

pFMEA

DOE

Description du poste

Aldevron, a Danaher company, is seeking a Senior Engineer, Process Validation to lead and support validation programs that enable commercialization of vital medicines. This role reports to the Process Validation Manager in Technical Operations and is fully remote, based in Fargo, ND.

You will apply pFMEA, DOE, and statistical analysis to validate sterile fill–finish, containers, and packaging, mentor junior staff, and collaborate with MSAT, manufacturing, QC, QA and RA.