Senior Engineer, Process Validation

About the role

Aldevron, a Danaher operating company, delivers world-class CDMO services that accelerate the development of groundbreaking therapies. As the Senior Engineer, Process Validation, you will lead and support internal and external validation projects enabling the commercialization of vital new life-saving medicines. This fully remote position reports to the Process Validation Manager within the Technical Operations Department.

Responsibilities

• Design, execute, and summarize deliverables across the three stages of process validation supporting process characterization and qualification spanning critical starting materials, drug substance, and drug product, 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 (e.g., process capability, trend analysis, control charts, DOE interpretation).
• Serve as a technical subject matter expert (SME) for process validation with external clients, internal teams (MSAT, manufacturing, QC, QA, RA), and during client audits, regulatory inspections, kaizens, and workshop events.
• Mentor junior validation associates in Process Validation, cGMP regulations, and principles of Quality by Design.

Requirements

• Bachelor’s or master’s degree in engineering.
• 5+ years of experience leading process development, engineering, and deliverables across all three stages of process validation in biologics/small and large molecule 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.
• Proficiency in technical writing for deviation investigations, root cause analysis, and risk assessments.
• Ability to travel 15% to support validation project executions, routine inspections, audits, and client visits.

Preferred Qualifications

• Experience in packaging and shipping validation of final product container closure configurations.
• Client-facing roles, such as prior experience in a CDMO environment.

Benefits

Aldevron offers a comprehensive package of benefits including:

• Paid time off.
• Medical, dental, and vision insurance.
• 401(k) retirement plan.

Pay

The annual salary range for this role is $100,000 to $130,000. This role is also eligible for bonus/incentive pay.

Schedule

This position is eligible for a fully remote work arrangement.