Senior Process Validation Engineer (Remote)

Danaher Corporation; Sunnyvale (CA); Remote; USD 100,000 - 130,000; Full time

Benefits offered by this job

Remote work eligibility

Competitive benefits

401(k) plan

Bonus eligibility

Job summary

Aldevron, a Danaher operating company, seeks a Senior Engineer, Process Validation to lead validation projects enabling the commercialization of new life-saving medicines. The role is fully remote and reports to the Process Validation Manager within Technical Operations in Fargo, ND, with travel as needed.

You will design, execute and summarize validation deliverables across sterile fill-finish, starting materials, drug substance, and drug product; apply risk-based methods and DOE; mentor junior

Qualifications

• Bachelor or master degree in engineering and 5+ years of experience.
• Prior experience in leading process development, engineering, and deliverables across all three stages of process validation in biologics/small and large molecules manufacturing train using statistical analysis, risk assessment, and process improvement tools required.
• 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.

Responsibilities

• Design, execute, and summarize deliverables across the three stages of process validation supporting process characterization and qualification spanning starting materials, drug substance, and drug product, product classifications aligned with FDA guidance, EU GMP Annex 15, and lifecycle approach.
• Lead the planning, execution, and lifecycle management of sterile fill-finish process validation strategies and qualification programs for aseptic manufacturing processes including sterile filtration, aseptic process simulation, sterile filling, visual inspection, container closure integrity testing, filter validation, labelling, packaging and shipping.
• Drive risk-based approaches using tools such as pFMEA, risk ranking, and criticality assessments and apply statistical tools to evaluate process performance, including but not limited to process capability, trend analysis and control charts and DOE) interpretation.
• Serve as a technical SME for process validation with external clients, across internal teams such as MSAT, manufacturing, QC, QA and RA, and during client audits and regulatory inspections, kaizens and workshop events.
• Mentor junior validation associates in Process Validation, cGMP regulations, and principles of Quality by Design

Skills

Process validation

Statistical analysis

Regulatory compliance

Risk management

Mentoring

Education

Bachelor's or Master in Engineering

Tools

pFMEA

Control charts

DOE

Job description

Aldevron, a Danaher operating company, seeks a Senior Engineer, Process Validation to lead validation projects enabling the commercialization of new life-saving medicines. The role is fully remote and reports to the Process Validation Manager within Technical Operations in Fargo, ND, with travel as needed.

You will design, execute and summarize validation deliverables across sterile fill-finish, starting materials, drug substance, and drug product; apply risk-based methods and DOE; mentor junior