Responsible for the facilitation, coordination, and execution of Validation strategies and protocols related to the utilities, computers, equipment, and processes associated with GMP activities. The position oversees and coordinates the activities of the validation resources.
Responsible for the technical direction of validation activities in the preparation and execution of validation protocols including facility, equipment and computer validation, but excluding analytical methods validation. This involves the tactical scheduling, staffing, and resource allocation of the Validation department.
Responsible for personnel development of subordinates and team members.
Develop and implement Validation strategies in compliance with Genentech policies, standards and regulations.
Ensure the timely completion of Project Team validation assignments.
Ensure execution of the validation of new facility expansions and construction projects.
Schedule contract validation resources to meet company objectives.
Responsible for on-time completion of validation activities according to overall current manufacturing schedule.
Ensure coordination of Validation requirements with Quality, Manufacturing & Engineering.
Conduct training on validation for cGMP employees.
All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
Ensure the integration of environmental health, safety, and security into the business processes, systems and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area. Foster a positive safety culture in which no one gets hurt.
May represent validation in project teams in the absence of the Manager.
May have to help validation efforts in other facilities if required
Education and Experience
BA/BS in Engineering or Life Sciences
8 years experience in the validation field of facilities, equipment and computers.
Knowledge, skills and abilities
Supervisory experience in execution of facility, equipment, and computer validation on large, complex biotech or pharmaceutical production project.
Expert in current validation requirements and FDA expectation of facility, equipment, and computer validation.
Good understanding and some experience in process validation and QC analytical method validation.
Ability to supervise internal validation technician and specialist staff (small teams).
Establish and maintain good relationships with external validation contractors and consultants.
Ability to manage and track validation progress in required detail with data basis and schedules.
Excellent team work skills.
Experience in FDA inspections, preferably including presenting to the FDA.
Work Environment/Physical Demands/Safety Considerations
Work in standard office environment.
May on occasion work in clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a load environment.
Maybe exposed to hazardous materials.
This position is not eligible for relocation.
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.