Remote Senior Process Validation Engineer - Life Sciences

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

Benefits offered by this job

Remote work arrangements

Bonus/incentive pay

Medical/dental/vision insurance

401(k)

Job summary

Aldevron, a Danaher operating company, seeks a Senior Engineer, Process Validation to lead validation programs enabling commercialization of life-saving medicines. This role reports to the Process Validation Manager within the Technical Operations Department and can be fully remote.

You will design, execute, and summarize validation deliverables across starting materials, drug substance, and drug product, using risk-based methods and regulatory know-how to support FDA and EU GMP standards.

Qualifications

• Bachelor or master degree in engineering and 5+ years of experience in process validation.
• Experience leading process development and validation across biotech manufacturing.
• Knowledge of global regulatory and cGMP requirements for pharma operations.

Responsibilities

• Lead and support process validation projects spanning starting materials to drug product.
• Plan and execute sterile fill-finish validation programs.
• Apply risk-based approaches and DOE interpretation.
• Serve as technical SME during audits and client visits.
• Mentor junior validation associates in cGMP and QbD.

Skills

Process validation

Regulatory knowledge

Technical writing

Statistical analysis

Risk assessment

Project leadership

Client-facing

Packaging validation

cGMP / GMP

Education

Bachelor or Master in Engineering

Job description

Aldevron, a Danaher operating company, seeks a Senior Engineer, Process Validation to lead validation programs enabling commercialization of life-saving medicines. This role reports to the Process Validation Manager within the Technical Operations Department and can be fully remote.

You will design, execute, and summarize validation deliverables across starting materials, drug substance, and drug product, using risk-based methods and regulatory know-how to support FDA and EU GMP standards.