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
Who You Are:
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
Operational excellence and industrial engineering skills are a plus
Professional level written and oral communication skills required
Relocation benefits are not available for this position.
The expected salary range for this position based on the primary location of Oregon is $95,200 to $176,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. 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.
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.