Sr. Validation Engineer (Contractor)

The Position

Main Purpose of the Position:

The Senior Validation Engineer will be accountable for performing validation activities such as Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV) / Process Validation (PV) and Revalidation (RV).

Contract duration: 12 months with possible extensions up to 3 years

Shift: Days, Monday to Friday, 8:00 am to 4:30 pm, weekends rotating on-call support

Pay Rate: $71/hour to $127/hour-Depending On Experience (DOE)

Responsibilities:

• Develop and manage the detailed project plans and timelines for the execution of validation activities.
• Support the change management system for validated equipment, utilities and facilities.
• Track and trend activities and report on issues such as impact to predetermined timelines and problems as needed.
• Support the development of manufacturing documents as appropriate.
• Provide input into investigations with potential validation impact.
• Coordinate the collection, testing and analysis of samples and reporting of results required per validation protocol.
• Prepare validation & change control documentation, including protocols, summary reports, etc., for validation activities.
• Act as project manager for validation deliverables ensuring new systems are implemented within predetermined timelines and financial forecasts.
• Lead the execution of CD/PQ/CV/PV/RV activities.

Qualifications / Requirements:

• Experience with cleaning and sterilization validation is required. Candidate must demonstrate understanding of cleaning and sterilization qualification requirements in cGMP environment.
• Professional level written and oral communication skills.
• Ability to work with internal teams, partners, suppliers and customers.
• Working knowledge of formulation, filling, and, packaging, equipment qualification in a regulated environment is required.
• Knowledge of cGMPs or equivalent regulations.
• Experience in the pharma/biotech industry is required.
• Operational excellence and industrial engineering skills are a plus.
• Experience authoring, reviewing, and executing validation protocols.
• BS/MS in chemical, biochemical engineering, or related field/experience, with a minimum of 8 years with a BS (6 years with MS) experience in drug product Process Research & Development, Engineering, Manufacturing, or Technical Services is required
• Demonstrated project management skills.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.