QC Software and Systems Lead (Solution Architect)

Roche•Indianapolis, IN

7d•Hybrid

About The Position

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. Near Patient Care at the Indianapolis site is involved in the entire value chain with Research & Development, Quality, Medical & Scientific Affairs, Production and Supply Chain to ensure that blood glucose monitoring systems and digital solutions reach patients all over the world. The approximately 750 employees work every day to provide real relief for people with diabetes, day and night. Quality Control (QC) is a function within NPC Internal Manufacturing Indianapolis organization, responsible for ensuring the products produced at the site are safe and effective for our patients. As a Solution Architect, you will assist in delivering and managing the lifecycle of internally and externally built software solutions, to ensure continuity in current product lines and to support the expansion of the site in producing Continuous Glucose Monitors. These solutions collect and analyze data from various Quality Control labs, and provide automated reports to support lot release. You will also be responsible for first level support of software systems within Quality Control in the event of outages or disruptions, across a two shift operation. The Opportunity: In collaboration with the Digital Operations Global Team, create and maintain a solution lifecycle roadmap based on gap analysis for transitioning from current to future-state, including the technology lifecycle management. Evaluate and provide strategic direction for new development initiatives. Continuously researching new technologies and industry standards. Coordinate the activities of other employees, cross functionally. Work in the area of IT:OT integration, with an emphasis on database administration, network design and implementation Take part in technical design reviews, integration, testing, and documentation activities, as part of a GxP regulated environment. Called upon for urgent and complex technical support to ensure product delivery. Exercise judgment in evaluating and developing methods and may determine criteria for obtaining solutions. Network with senior internal and external personnel in area of expertise as well as some key contacts outside area of expertise. Provide technical support for Quality Control applications to end users and key business users. (On-call support, including regular intervals outside of regular working hours: 7am through 10pm).

Requirements

Bachelor’s degree in Computer Science, Information Systems or other related field and at least 7 years related experience
Knowledge of manufacturing process design, in life sciences, or similar
Experience with SAS Programming and/or Oracle/Microsoft SQLServer Databases, C# and Java Programming, or equivalent
Strong project management skills with expertise in overseeing initiatives from initiation through closure, including detailed planning, stakeholder coordination, and thorough documentation.
Experience with networking and protocols (ex, SSL, SSH, NTP, R/SPAN, VLAN, ACL, NAT)
Experience with firewall concepts, implementation, and troubleshooting
Familiarity with Computer System Validation.
Capable of working in a GMP regulated environment
You can explain technical requirements and solutions to a broad range of stakeholders
You have strong attention to details and good problem-solving skills
You are a seasoned professional with wide-ranging experience and can deal with broad and oftentimes complex issues, where analysis may require in-depth evaluation of many factors
You are capable of gathering user requirements and translating them to system requirements

Responsibilities

In collaboration with the Digital Operations Global Team, create and maintain a solution lifecycle roadmap based on gap analysis for transitioning from current to future-state, including the technology lifecycle management.
Evaluate and provide strategic direction for new development initiatives.
Continuously researching new technologies and industry standards.
Coordinate the activities of other employees, cross functionally.
Work in the area of IT:OT integration, with an emphasis on database administration, network design and implementation
Take part in technical design reviews, integration, testing, and documentation activities, as part of a GxP regulated environment.
Called upon for urgent and complex technical support to ensure product delivery.
Exercise judgment in evaluating and developing methods and may determine criteria for obtaining solutions.
Network with senior internal and external personnel in area of expertise as well as some key contacts outside area of expertise.
Provide technical support for Quality Control applications to end users and key business users. (On-call support, including regular intervals outside of regular working hours: 7am through 10pm).