Job Description

The Position

This role centers on the dynamic landscape of the validated Data Computation Platform (DCP) and its associated modules, operating seamlessly in both GxP and non-GxP capacities. DCP plays a pivotal role in empowering our development and manufacturing network through sophisticated analytics for process monitoring. As a Digital Solution Operational Expert within the OpenGMP DevOps & Innovation team, housed in the Data Analytics chapter of PT Operational Excellence (PTE), you will be at the forefront of guiding DCP from a validation standpoint while providing crucial support to business operations.

The primary objective is to pioneer novel approaches that accommodate both validated and non-validated applications within the same platform. This necessitates the application of cutting-edge validation methodologies and strategies. Success in this role hinges on possessing a comprehensive, end-to-end mindset that encompasses validation and business process optimization. The ability to take ownership of tasks on an ad-hoc basis is paramount for achieving success in this dynamic and critical position.

Role Responsibilities:

The scope of accountabilities will integrate development, validation and business operational activities in both an internal and open source framework, including but not limited to the following tasks and roles:

Validation:

Collaborate with global teams across Roche and affiliates to ensure compliance with cGMP regulations and company standards for the DCP platform, its modules, and mathematical data models.

Author and review validation documentation throughout the system\'s lifecycle.

Conduct risk assessments to identify and address potential compliance and quality issues, developing effective mitigation plans.

Maintain precise and streamlined lean validation documentation adhering to regulatory requirements and fitting seamlessly into the Roche validation landscape.

Identify opportunities for automation to streamline validation processes and boost productivity.

Innovate, build, revise, and optimize Qualification/Validation business processes in line with industry best practices and standards.

Collaborate with cross-functional teams at multiple sites, including Quality, Manufacturing, and Engineering, ensuring successful cGMP compliance and adherence to company validation strategies.

Stay current on industry regulations, guidelines, and best practices to uphold continued compliance with regulatory standards.

Business & Operations:

Accountable for user support of the framework and modules, responsible for authoring user requirements/enhancement specifications.

Interpret and communicate findings to cross-functional teams, facilitating data-driven decision-making.

Support customers in developing predictive models, implementing, and optimizing them to enhance data-driven decision support systems.

Support the development of software solutions in collaboration with partners, leveraging existing infrastructure and tools.

Design and implement robust data pipelines for collecting, cleaning, and storing structured and unstructured data from various sources.

Identify, analyze, and implement use cases for increased efficiency in data processes (e.g. via automation, data processing) and decision-making within Pharmaceutical Sciences.

Assess, analyze, and optimize end-to-end business processes related to pharmaceutical operations, ensuring efficiency, compliance, and quality.

Collaborate with stakeholders across departments, including R&D, manufacturing, regulatory affairs, and quality assurance, to understand process requirements and ensure seamless integration.

Ensure all business processes adhere to regulatory requirements, industry standards, and internal quality management systems.

Lead change initiatives related to process improvements, providing guidance and support to ensure successful implementation.

Who you are:

You are an individual with a proclivity for embracing new ideas, challenging conventional paradigms, and achieving goals through a structured and diligent work approach. Your strength lies in effective communication across various levels, fostering constructive relationships with stakeholders, partners, and team members. Your expertise extends to digitalization, encompassing development, validation, and business operations, demonstrating a commitment to driving innovation.

In addition to these competencies, you bring the following qualifications:

Bachelor\'s/Master\'s Degree in life science, information technology, engineering, or an equivalent field.

5 or more years of relevant experience in a regulated industry, preferably within a global Pharma CSV environment.

Proficiency in operating CSV compliant software and integrating innovative, lean validation approaches, leveraging recent advancements from health authorities.

Proficient in scientific programming languages (e.g., Python or R) to apply mathematical and statistical approaches for integrating, processing, and reporting continuous and discrete manufacturing data.

Basic knowledge of upstream and downstream drug substance manufacturing, and/or an understanding of GMP requirements and industry practices for reporting manufacturing data.

Experience in software development/application engineering of modular solution architectures, ideally with a web application technology stack, and expertise in data source integration (OSIsoft PI/Aveva is a plus).

Demonstrated strong oral and written communication skills.

Strong collaboration and team-building capabilities across diverse cultures, countries, technical competencies, and organizational levels.

Proven ability to drive results, foster innovation, and lead change.

Excellent communication skills to effectively convey complex findings to non-technical stakeholders.

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** Relocation benefits not eligible for this position**

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we\xe2\x80\x99ve become one of the world\xe2\x80\x99s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche\'s truly innovative culture.

As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely. If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and / or adaptation measures regarding this vaccination requirement.

Roche is an Equal Opportunity Employer.

Roche