Senior Compliance/Validation Engineer

Are you passionate about Information (IT) and Automation Technology (OT) and aspiring to make a meaningful impact? Are you curious to shape a digital manufacturing architecture, ready to advance competitiveness on the market?

We Make Medicines!

Behind every product sold by Roche is Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes lifesaving medicines at 11 locations, with the support of partners from around the world. Information (IT) and Automation Technology (OT) teams are key in producing and delivering medicine to patients. The organization is currently undergoing a transformation towards digitalization, advancing fundamental elements to meet future needs, such as using new technologies.

Who we are:

This position, based in Genentech's Oceanside, California facility, provides the opportunity to have a key role in a highly automated pharmaceutical drug substance facility. The site employs highly integrated computer control systems to manage plant operations and manufacturing data. The candidate will report to the Site Head of IT/OT, an organization that is currently undergoing a transformation towards digitalization, advancing fundamental elements to meet future needs, such as standardizing and leveraging new technologies.

The IT OT Team in Oceanside is supporting Oceanside manufacturing (OCN) which is the commercial Make Assess and Release (MAR) and launch site for North America.As part of the Oceanside IT OT team you will have responsibilities for IT OT compliance and Validation ensure compliance for all IT Systems. As part of the Site Team and larger Global IT OT organization, you will also be expected to contribute to Manufacturing Operations initiatives and optimization/standardization of the global IT OT landscape.

Mission:

• Act as Compliance Officer for the local IT OT Team.

• Ensure adherence to cGMP, GSP 111, and CSV 6 requirements across all operations.

• Develop, implement, and maintain compliance policies and procedures.

• Ensure compliance with industry standards and regulations for data protection.

• Manage exceptions/CAPA/Deviations for ITOT to meet the defined timelines without extensions.

• Manage IT quality topics such as change management process.

• Manage/lead validation activities for key ITOT systems projects/changes.

• Represent ITOT in internal(SSI, GARA, quality etc.) and external audits(FDA etc.).

• "Right to Operate" : Manage ITOT systems periodic reviews, manage user access reviews, project documents as per GSP/CSV requirements.

• Work effectively with other quality/manufacturing stakeholders.

• Represent ITOT in key deviations management meetings.

• Define and monitor key KPIs or metrics to meet timelines(Connected Outcome).

• Proactively manage training matrix for ITOT and enforce timely completion of assigned training.

• Tracking, monitoring and reporting issues via ServiceNow ticketing system.

• Any other duties as assigned/requiredfor compliance/validation of ITOT systems/processes.

Who you are:

• Has business domain knowledge for the following area(s): Biopharmaceutical or similar Manufacturing domain.

• Minimum of 8+ years of experience in an IT and/or OT compliance/Validation role within the biotechnical or pharmaceutical industry.

• Proven experience with cGMP, GSP 111, and CSV 6 regulations.

• Knowledge and understanding of how business processes translate into ITOT system(MES, DeltaV, OSI-PI and SAP) processes is a must.

• Working knowledge of ServiceNow(incidence, change management, problem management), Veeva(Deviations, PE's and CAPA) and eValRoche.

• Excellent written and verbal communication.

• Good negotiation skills.

• Collaborative skills to work effectively with internal(ex : system owners) and external stakeholders.

Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of California is $92,600 to $172,000.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

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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.