Cleaning Program Ownership

• Responsible for identifying and implementing improvements for cleaning and sanitization of OCN GMP areas including aseptic cleaning.
• Ensure that all GMP cleaning operations are performed with 100% compliance to GMP standards.
• Ensure maintenance of a safe manufacturing work environment that complies with company and state regulations.
• Manage project teams to troubleshoot and proactively minimize potential for microbial contamination in the manufacturing clean rooms.
• Identify the technical, procedural and equipment issues that may compromise production and compliance. Work with cross-functional groups to identify and implement solutions.
• Represent the OCN GMP areas in reviewing and approving production related documentation such as: process validation protocols, planned and unplanned variance reports, documentation change requests, engineering and facility change requests, and production schedules.
• Performs routine audits and periodic spot inspections on GMP cleaning operations to observe and evaluate health of the cleaning program.

Leadership Management

• Responsible for oversight of training and review of appropriate headcount to sustain cleaning program.
• Oversee GMP cleaning and sanitization staff training program and qualifications.
• Support and oversee the cleaning team’s training compliance program along with the review of corresponding training curriculum.
• Evaluate data and provide input to Site Services and Janitorial Services on cleaning staff performance and/or problem areas.
• Establish Key Performance Indicators and scores to ensure health of the program.

Vendor and Customer Relationship Management

• Work collaboratively with Manufacturing, Quality, Site Services, Janitorial Services, Facilities, and SHE to ensure that appropriate cleaning programs have been established for all OCN GMP areas, including uncontrolled and unclassified areas within the Manufacturing, Production Services and Spine.
• Act as a single point of contact for OCN GMP Operations with Janitorial Services.
• Partner with Site Services and Janitorial Services to ensure appropriate resources are allocated to support GMP cleanings.
• Set expectations with Vendors to ensure Cleaning program robustness.

Compliance

• Review and approve GMP cleaning related documentation in OCN.
• Manage and resolve technical and compliance issues and investigations with Manufacturing, Quality, Maintenance, and SHE.
• Oversee prompt closure of Adverse Trends through corrective action implementation associated with cleaning of GMP areas in OCN.
• Partner with Environmental Quality Assurance and Quality Control to investigate all microbiological control failures and contribute to microbiological assessments of potential and actual adverse trends associated with cleaning and sanitization of GMP areas in OCN.
• Participate in investigations of significant event deviations along with the corresponding root cause analysis(RCA), impact assessment and trend evaluations
• Support SHE teams in full compliance with all SHE programs requirements.
• Lead assigned Corrective and Preventive Actions (CAPA)
• Lead regulatory and quality assurance programs and requirements by ensuring all cleaning services and documentation is in full accordance and compliance with Genentech policies and procedures and FDA (and other health authority) cGMP regulations.
• Lead in the completion of cleaning audits and assessments requirements, and full responsible of site audit readiness program in regards to cleaning.

Job Requirements

Education and Experience

Minimum of 2 years site lead and/or facilities management in the janitorial industry or similar industrial background helpful.

Knowledge, Skills, and Abilities

• Thorough understanding of Aseptic Techniques/Processes
• Thorough knowledge and understanding of cGMPs
• Thorough working knowledge of safe work practices in a manufacturing environment
• Strong interpersonal skills
• Experience with Veeva system and ownership responsibilities for Planned and Unplanned events

Work Environment / Physical Demands / Safety Considerations

Be able to work extensive hours while standing, sitting, or bending as necessary

Working with/around various chemicals (i.e. acids and bases), solvents, pressurized systems, compressed gases, and biological materials (Recombinant DNA)