Manufacturing Compliance Engineer

Are you passionate about innovation and excellence in manufacturing? Join our dynamic team as a Manufacturing Compliance Engineer, where you'll play a pivotal role in enhancing our departmental capabilities to meet corporate needs, industry best practices, and regulatory expectations. You'll act as a key coordinator and problem solver across Biochemical Manufacturing Operations, ensuring seamless collaboration with various groups and projects.

In this role, you'll ensure that our quality system records adhere to the highest regulatory standards by utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Your keen eye for detail will be essential in the critical review and approval of documentation related to the design, validation, operation, and maintenance of our biochemical manufacturing processes, equipment, and facilities.

You'll work closely with MSAT, Compliance, and Quality Assurance teams to resolve quality issues and lead operational excellence initiatives. Your efforts will help us solve complex problems while maintaining the highest levels of safety, quality, regulatory compliance, and production. By joining our team, you will be fully accountable for compliance with all laws, regulations, and policies that govern our activities and contribute to our mission of excellence in GMP Services

The Opportunity

• Support resolution of technical and compliance issues with various departments including Quality, Technology, Maintenance, Facilities, Calibration, and EH&S.

• Assist in managing and reducing unplanned events by proposing and implementing changes, and performing track and trend analysis for these events.

• Conduct audits, including area access audits for Manufacturing, and ensure operations comply with cGMP standards and Genentech guidelines.

• Provide technical assessments for controlled document changes, review and approve Change Requests, and participate in discrepancy investigations to ensure resolution.

• Lead or facilitate Root Cause Analysis sessions for complex issues and oversee the implementation of corrective and preventative actions (CAPA) within set timelines.

• Collaborate with cross-functional teams to identify and resolve technical, procedural, and equipment issues that may affect production and compliance.

• Ensure a safe manufacturing work environment that complies with company and state regulations, and act as a Subject Matter Expert (SME) on quality systems for regulatory agencies.

Who you are

• BS/BA in Life Sciences/Engineering preferred, and at least 3 years' experience in the pharmaceutical, biopharmaceutical industry or a combination of education and experience.

• Ability to make sound decisions about scheduling, allocation of resources and managing of priorities.

• Direct experience with mammalian cell culture and/or purification of biopharmaceutical products, and familiarity with cGMPs, FDA, ICH, and European guidelines.

• Strong oral and written communication skills, with proficiency in Google Suite and technical writing, including the creation and revision of SOPs or technical reports.

• Ability to make sound decisions with minimal supervision, manage complex assignments independently, and demonstrate a high degree of initiative in problem-solving and developing recommendations.

Work Environment/Physical Demands/Safety Considerations

• Environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn.

• 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.

• May work with hazardous materials.

Relocation benefits are not available for this posting

The expected salary range for this position based on the primary location of California is $69,300-$128,700. 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. 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.