The Position
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.
Oceanside Operations (OCN) is a drug substance manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products. The Operations organization at OCN is divided into 2 value streams (Stainless Steel and Single use), which combine to produce millions of units of life-saving medicine every year to patients around the world.
The Opportunity:
In this exciting role, you will apply knowledge of qualification and validation principles, manufacturing processes, quality systems, engineering design fundamentals, health authority expectations and industry standards, review and approve qualification and validation documents. You will be responsible for the implementing and maintaining the validated state of the equipment, facility and utility systems, drug substance manufacturing processes, cleaning processes and sanitization/sterilization processes. This is inclusive of tech transfer oversight, projects as well as Make-Assess-Release (MAR) activities. You are also responsible for validation contractor oversight, demonstrating leadership skills and modeling Genentech values and core competencies while working closely with Engineering, MSAT, Quality Assurance and Manufacturing. This position requires strong communication and collaboration skills, the ability to work within teams, facilitate meetings and lead teams.
- Manage and track the Validation program and assigned validation projects and ensure target timelines are met and/or issues are communicated / escalated effectively and consistently.
- Generate, review, approve and maintain Validation Project Plans and Summary Reports and other validation lifecycle documents, SOP changes, Engineering commissioning and turnover packages.
- Generate, review and approve a variety of Qualification protocols (IQs, OQs, IOQs, PQs) for equipment, facilities and utilities as well as support Cleaning and Process Validation
- Manage protocol execution, perform data review and manage deviation resolution.
- Oversight and management of validation contract resources including work prioritization, and execution.
- Strong understanding of commercial production environment and requirements.
- Evaluate and audit the current validated status of equipment/systems. This may also include temperature mapping and cleaning validation program.
- Proven ability to make suggestions for improvements as well as ensure programs are operating in a compliant and validated state.
- Present validation packages as required for audits and/or regulatory inspections.
- Perform role of subject matter expert and assess change control and discrepancy events for validated systems.
- Participate in cross-functional team meetings and where required, lead/facilitate meetings.
- Review validation lifecycle documents for compliance with CFRs, corporate policies (PQS documents), and site procedures (SOP’s)
- 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.
Who you are:
- BS degree in Engineering or relevant scientific discipline.
- 4 - 6 years combined engineering/validation experience in a federally regulated industry.
- Minimum of 4 years validation experience in the pharmaceutical/biotechnology industry.
- Minimum of 3 years hands-on experience with equipment / utility / data review and analysis in a batch manufacturing environment.
- Quality and Regulatory Knowledge: Must understand Quality standards, GMPs, Health Authority Regulations, cGMP regulations, Validation practices, and general compliance principles.
- Technical and System Expertise: Experience with CHO based manufacturing processes, Delta V automation system, Syncade and electronic Validation Execution. Hands-on experience commissioning/validating GMP equipment/utilities preferred.
- Audit and Communication Skills: Audit or inspection experience preferred, excellent verbal and written communication skills, and proven ability to manage multiple activities while maintaining organization.
- Teamwork and Initiative: Demonstrates initiative, problem anticipation, familiarity with project management principles, ability to work effectively in customer service/business partner roles, and strong collaboration skills with staff at all levels.
Work Environment/Physical Demands/Safety Considerations
- Works in an office environment.
- Not a remote opportunity, expectation is to be onsite to support operations
- On occasion my work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no make-up or jewelry can be worn when working in the clean room environment.
- May be exposed to hazardous materials and chemicals.
- May be required to lift up to 30 lbs.
Relocation benefits are not available for this posting.
The expected salary range for this position based on the primary location of California is $81,000 to $150,400. 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.
Benefits
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.