Principal Validation Engineer: Drug Product & Packaging

F. Hoffmann-La Roche AG; Holly Springs (MS); On-site; USD 95,000 - 212,000; Full time

Benefits offered by this job

Relocation benefits

Discretionary annual bonus

Job summary

Genentech is seeking a Principal/Senior Principal Validation Engineer for a greenfield Holly Springs site. You will own validation strategies for high-speed PFS assembly, packaging lines, and facilities, collaborating across QA, Automation, and Maintenance.

Onsite work required with potential relocation considerations. The role requires 5–7 years (Principal) or 8–11 years (Senior Principal) in drug product fill finish, strong cGMP knowledge, and experience in PQ/PPQ, change controls, and

Qualifications

• BS/MS in chemical, biochemical engineering or related field/experience.
• 5-7 years (Principal) and 8-11 years (Senior Principal) experience in drug product fill finish/packaging, Engineering, Manufacturing, or Technical Services.
• Knowledge of cGMPs and regulatory requirements.
• Experience in equipment qualification, process validation, and technology transfers.

Responsibilities

• Define, execute, and maintain validation strategy for high-speed assembly and packaging lines.
• Author and review PQ/PPQ protocols, sampling plans, and reports.
• Lead New Product Introductions, capital expansions, and tech transfers.
• Provide technical leadership and mentorship to junior engineers and contractors.
• Ensure compliance with regulatory submissions and audits.

Skills

Validation engineering

Project management

Regulatory compliance

Cross-functional collaboration

Leadership

Written and oral communication

Education

BS/MS in chemical/biochemical engineering

Job description

Genentech is seeking a Principal/Senior Principal Validation Engineer for a greenfield Holly Springs site. You will own validation strategies for high-speed PFS assembly, packaging lines, and facilities, collaborating across QA, Automation, and Maintenance.

Onsite work required with potential relocation considerations. The role requires 5–7 years (Principal) or 8–11 years (Senior Principal) in drug product fill finish, strong cGMP knowledge, and experience in PQ/PPQ, change controls, and