Remote Senior Process Validation Engineer – Life Sciences

Aldevron; Dallas (TX); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Remote work arrangements

Job summary

Aldevron is seeking a Senior Engineer, Process Validation to lead validation projects enabling commercialization of vital medicines. The role reports to the Process Validation Manager within Technical Operations and offers remote work options, with 15% travel to client sites.

The ideal candidate has 5+ years in process validation within biologics/small and large molecules, strong statistical and writing skills, and a track record in cGMP and regulatory compliance for pharmaceutical manufacturing.

Qualifications

• Bachelor or Master degree in engineering and 5+ years of experience.
• Experience leading process development across all three stages of process validation in biologics/small and large molecules manufacturing.
• Knowledge of global regulatory requirements and cGMP regulations for pharmaceutical manufacturing operations.
• Proficiency in technical writing with deviation investigations, root cause analysis, and risk assessments.
• Ability to travel 15% to site to support validation project executions, inspections, audits, and client visits.
• Experience in packaging and shipping validation of final product container closure configurations.
• Client-facing experience in a CDMO environment.

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.
• Lead the planning, execution, and lifecycle management of sterile fill‑finish validation strategies for aseptic processes including sterile filtration and filling.
• Drive risk-based approaches using pFMEA, risk ranking, and criticality assessments and apply statistical tools to evaluate process performance.
• Serve as a technical SME for process validation with external clients and internal teams, and support audits and regulatory inspections.
• Mentor junior validation associates in Process Validation, cGMP regulations, and Quality by Design.

Skills

Process Validation

Regulatory compliance

Technical writing

Client-facing

Data analysis

Education

Bachelor or Master degree in engineering

Tools

pFMEA

DOE interpretation

Control charts

Statistical analysis

Risk assessment

Job description

Aldevron is seeking a Senior Engineer, Process Validation to lead validation projects enabling commercialization of vital medicines. The role reports to the Process Validation Manager within Technical Operations and offers remote work options, with 15% travel to client sites.

The ideal candidate has 5+ years in process validation within biologics/small and large molecules, strong statistical and writing skills, and a track record in cGMP and regulatory compliance for pharmaceutical manufacturing.