Principal Validation Engineer

Roche • Hillsboro, OR

1d • $5,200 - $176,800

About The Position

Under the direction of the Director of Validation, the Principal Validation Engineer will be accountable for performing activities such as Equipment Commissioning and Qualification, Cycle Development (CD), Performance Qualification (PQ) and Re-Qualification (RPQ) / Cleaning Validation (CV) and Process Validation (PV) in support of technology transfer and new technology introduction to the HTO site. The Opportunity Develop and manage the detailed project plans and timelines for the execution of validation activities. Prepare change control documentation, including protocols, summary reports, etc., for all activities. Support project manager ensuring new systems are implemented within predetermined timelines and financial forecasts. Present and provide rationale for completed work during periodic audits and Health Authority inspections. Procure and manage contractor support for outsourced validation and risk management assignments. Support the change management system for new processes, equipment, utilities and facilities. Prepare, review and approve relevant sections of regulatory submissions. Serve as a risk management representative on cross-functional and multi-site teams to support integrating risk management into various Product Quality Systems (PQS) such as, Discrepancy Management, Change Control and CAPA. Lead and facilitate Risk Assessment sessions. Provide input into investigations and change control with potential impact to the site risk profile. Foster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements. Mentor more junior validation engineers and train individuals on practices and procedures. Closely collaborates with site and network organizations seamlessly Constantly in search of the most creative and innovative solutions to maintaining the highest levels of productivity Able to provide the leadership necessary to maintain a high performance culture

Requirements

• BS/MS in chemical, biochemical engineering, or related field/experience, with a minimum of 8+ years experience in drug product Process Research & Development, 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.
• Demonstrated project management skills.
• Ability to work with internal teams, partners, suppliers and customers.
• Professional level written and oral communication skills required.

Nice To Haves

• Operational excellence and industrial engineering skills are a plus.

Responsibilities

• Perform activities such as Equipment Commissioning and Qualification, Cycle Development (CD), Performance Qualification (PQ) and Re-Qualification (RPQ) / Cleaning Validation (CV) and Process Validation (PV) in support of technology transfer and new technology introduction to the HTO site.
• Develop and manage the detailed project plans and timelines for the execution of validation activities.
• Prepare change control documentation, including protocols, summary reports, etc., for all activities.
• Support project manager ensuring new systems are implemented within predetermined timelines and financial forecasts.
• Present and provide rationale for completed work during periodic audits and Health Authority inspections.
• Procure and manage contractor support for outsourced validation and risk management assignments.
• Support the change management system for new processes, equipment, utilities and facilities.
• Prepare, review and approve relevant sections of regulatory submissions.
• Serve as a risk management representative on cross-functional and multi-site teams to support integrating risk management into various Product Quality Systems (PQS) such as, Discrepancy Management, Change Control and CAPA.
• Lead and facilitate Risk Assessment sessions.
• Provide input into investigations and change control with potential impact to the site risk profile.
• Foster an environment that encourages continuous learning.
• Maintain expertise as necessary to stay abreast of technical and industry advancements.
• Mentor more junior validation engineers and train individuals on practices and procedures.
• Closely collaborates with site and network organizations seamlessly.
• Constantly in search of the most creative and innovative solutions to maintaining the highest levels of productivity.
• Able to provide the leadership necessary to maintain a high performance culture.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• This position also qualifies for the benefits detailed at the link provided below.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal