Job Description

This is a fixed-term position with an estimated duration through November 2024 (1 year). There may be a potential for extension (s) and/or conversion depending upon the business needs and availability of headcounts.

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.

Mission:

As an ERP Systems Support Lead, based at Genentech's Hillsboro, Oregon facility, you will assume 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. This role 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 Hillsboro is supporting Hillsboro Technical Operations (HTO) which is the commercial Make Assess and Release (MAR) and launch site for North America and Hillsboro Individualized and Cell Therapies (HIT) which is transitioning into a multi-product facility for development, clinical and commercial supply capabilities for individualized and cell therapies.

As part of the Hillsboro IT OT Leadership team, you will support the introduction of the Global SAP HANA System rollout as the IT Lead for HTO and build up a Team of System Process Specialists to support the ERP System after the go-Live date in October 2024.

What You Will Do

As the Aspire IT Lead for HTO, you will be responsible to work with the project on mitigating the impact of the SAP HANA introduction to local systems and interfaces.

Support the introduction of the Global SAP HANA System (Project ASPIRE) during the project and build up the ERP Systems Support Team during the project to ensure a smooth transition into operations after Go-Live in October 2024.

This role is an individual contributor to start off with but eventually this person will be building a team - hire for open roles, coach and train new employees, and own training curriculum.

Accountable for ERP Systems Support in a 24/7 GMP Manufacturing environment

Work to identify opportunities to create additional value and improve business processes and patient outcomes, maximize the benefits of standardization of technologies and leverage across sites.

Determine business criticality and product quality requirements, and in collaboration with the Business Integration Managers, ensure appropriate service levels, Disaster Recovery procedures, governance, change management, compliance and operational support.

Lead or coordinate technical discussions with the Global SAP HANA Team.

Lead proposal development for local and global digital governance bodies, collaborate with Site Business Integration Managers to meet the needs of HTO and HIT.

Through Agile delivery model, provide leadership, technical expertise and local implementation experience as a member of Build and Run Squads.

In collaboration with the Business Integration Managers, monitor and improve stakeholder and user experience and ensure strong support of Product Transfers and Make/Assess/Release.

Member of the site IT OT run Squad and Site IT OT leadership Team

Continuous Improvement

Support/Lead Continuous Improvement opportunities related to ITOT applications/systems.

Regular exchange with the Support network and or BPMs on support cases, best practices and process improvement proposals with network relevance.

Help the End User to submit new ideas for process improvements, allowing a comprehensive approach for assessing both the process interdependencies as well impact to all underlying systems.

Describe the full lifecycle of an integrated Change process to Business Process with System impact. This Framework combines the Assessment of the requirement, Build and Test work as well as Deployment and eventually delivery of the added value to the End User.

Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.

Onboarding & Training

Coordinate and conduct End User training.

Support user authorization workflows (e.g. request, verify training, approve).

Add information to the knowledge base.

Create/Review Knowledge Articles.

Create/Review training material.

Initiate knowledge management process.

Qualifications:

Bachelor’s degree in Informatics, Engineering, or equivalent.

7+ years of experience with SAP Projects or Managing an SAP Support Team.

Knowledgeable about integration with enterprise business systems (SAP, MES, LIMS, etc.) and data integrity concepts.

Exhibits intellectual curiosity and integrity and has a strong passion to bring value-adding technology to the business.

Entrepreneurial mindset e.g. "automating automation".

Primary Skills

Experience or familiarity with SAP HANA is a big plus. Experience in biotech/pharmaceutical manufacturing GMP domain is desired. Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11, cGMP Annex 11, Data Integrity p

Secondary Skills

Strong analytical skills for effective troubleshooting and problem solving. Candidates must be self-driven and able to work well with others as a team member. Strong technical writing and verbal communication skills. Excellent customer service skills a