Remote Senior Process Validation Engineer

Aldevron; Raleigh (NC); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Remote work arrangements

Full benefits package

Job summary

Aldevron, a Danaher company, is hiring a Senior Engineer, Process Validation. This role leads validation programs for aseptic and fill‑finish processes, collaborating with MSAT, manufacturing, QA, and RA. The position supports client audits and regulatory inspections and requires travel up to 15%.

Remote work is available, with the Technical Operations team based in Fargo, ND. A bachelor or master in engineering and 5+ years’ experience in biologics/small & large molecules validation are

Qualifications

• Bachelor or master degree in engineering and 5+ years of experience.
• Experience leading process development and validation across biologics/small & large molecules.
• Knowledge of global regulatory requirements and cGMP in pharmaceutical manufacturing.
• Proficiency in technical writing with deviation investigations and risk assessments.
• Ability to travel 15% to site to support validation projects, inspections, audits, and client visits.

Responsibilities

• Design, execute, and summarize process validation deliverables across materials, drug substance, and drug product.
• Lead sterile fill-finish validation strategies and qualification programs.
• Apply risk-based approaches and statistical tools to evaluate process performance.
• Serve as SME for process validation with internal teams and external clients, and during audits/inspections.
• Mentor junior validation associates in cGMP and Quality by Design.

Skills

Technical writing

Client-facing

Analytical skills

Education

Bachelor or Master degree in engineering

Job description

Aldevron, a Danaher company, is hiring a Senior Engineer, Process Validation. This role leads validation programs for aseptic and fill‑finish processes, collaborating with MSAT, manufacturing, QA, and RA. The position supports client audits and regulatory inspections and requires travel up to 15%.

Remote work is available, with the Technical Operations team based in Fargo, ND. A bachelor or master in engineering and 5+ years’ experience in biologics/small & large molecules validation are