Lead Validation Engineer — Pharma Manufacturing Relocation

F. Hoffmann-La Roche AG; Holly Springs (MS); On-site; USD 95,000 - 176,000; Full time

Benefits offered by this job

Relocation benefits

Job summary

Genentech, a member of the Roche group, is expanding a state-of-the-art plant in Holly Springs, NC and seeks a Principal Validation Engineer with 8+ years in drug product processes to lead qualification and validation efforts. You will guide equipment commissioning, PV/CV, and technology transfer initiatives in a fast-paced, highly accountable environment.

You will collaborate with cross-functional teams, manage timelines, prepare regulatory submissions sections, and mentor junior engineers

Qualifications

• BS/MS in chemical, biochemical engineering, or related field/experience with a minimum of 8+ years in drug product Process R&D, Engineering, Manufacturing, or Technical Services is required.
• Experience in the pharma/biotech industry is required.
• Knowledge of cGMPs or equivalent regulations.
• Working knowledge of facilities, utilities, formulation, filling, and packaging, equipment qualification in a regulated environment is required.
• Hands on qualification experience with the majority of sterile filling equipment and support systems.
• Demonstrated project management skills.
• Ability to work with internal teams, partners, suppliers and customers.
• Operational excellence and industrial engineering skills are a plus.
• Professional level written and oral communication skills required.

Responsibilities

• Develop and manage detailed project plans, validation plans and timelines for validation activities.
• Author, execute and summarize qualifications for sterilization systems, cleaning, filling and supporting equipment.
• Prepare change control documentation, including protocols and summary reports.
• Support project manager to meet timelines and budgets; present findings during audits and inspections.
• Lead risk assessments and serve as a risk-management representative in cross-functional teams.

Skills

Project management

Regulatory understanding

Written & oral communication

Education

BS/MS in chemical, biochemical engineering, or related field

Job description

Genentech, a member of the Roche group, is expanding a state-of-the-art plant in Holly Springs, NC and seeks a Principal Validation Engineer with 8+ years in drug product processes to lead qualification and validation efforts. You will guide equipment commissioning, PV/CV, and technology transfer initiatives in a fast-paced, highly accountable environment.

You will collaborate with cross-functional teams, manage timelines, prepare regulatory submissions sections, and mentor junior engineers