Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products. The Operations organization at HTO is divided into 2 value streams, 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 work closely with Roche/Genentech Global MSAT & Engineering, the Internal Manufacturing Network, and all site Manufacturing and Quality groups in troubleshooting, evaluating, problem solving, and optimization of the existing utility systems at HTO. You will support cross-functional project teams in the delivery of expense/capital projects at HTO and will interact with and successfully present information to domestic and international regulatory agencies.
You will develop end-to-end utility system asset management, including plan, design, commissioning, qualification, maintain and decommission, through the application of good engineering practices and troubleshooting methodologies.
You will collaborate with site functions and Global MSAT & Engineering on facility modifications, process expansions and new installations.
You will present end to end utility system overview and defense for internal and domestic and international regulatory inspections
You will collaborate with maintenance staff in the continuous improvement of technical infrastructure required to support Utility equipment and systems, including specifications, procedures, and implementation of best maintenance practices.
You will lead or support discrepancy evaluations, CAPAs, and Quality investigations.
You will manage Change Records that drive improvements and corrections in utility systems
You will provide technical SME reviews for any changes impactful to Utilities and Utility Maintenance related documents..
You will prepare and deliver presentations of project results to others; present data to larger and more diverse audiences.
Who you are:
You hold a bachelor’s degree in engineering discipline
You have a minimum 4 years working in a GMP manufacturing environment providing utilities support for Drug Product or Drug Substance equipment.
You have 4 years of experience in Utilities specific equipment and systems.
You have demonstrated expertise in GMP clean water systems including reverse-osmosis water, water-for-injection, and pure steam systems and other non-GMP utilities.
You have strong technical leadership and must be able to function in a team environment, interacting with various functional groups, as well as in a self-managed environment
You have effective communication and interpersonal skills and are able to communicate information accurately and concisely, both verbally and in writing, to a diverse audience, in particular Manufacturing, Quality, SHE, Global MSAT & Engineering, and site leadership.
You are proficient in operation and use of utilities systems and maintenance management software (BAS, DeltaV, SAP, Desigo)
You are proficient in operation and use of Quality Systems software (Trackwise, Veeva Vault, eVALRoche)
You have an appreciation of industry standards, codes and construction practices
The expected salary range for this position based on the primary location of Hillsboro, Oregon is $78,000 to $144,000. 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
Relocation benefits are available
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.