Industrial Applications Specialist

Septodont•Cambridge, ON

7d•Hybrid

About The Position

Septodont is a global leader in dental pharmaceuticals and medical devices, with operations in North America including facilities in Ontario and Pennsylvania. The Cambridge, Ontario site, Novocol Pharma, is a center of innovation with expertise in sterile injectable cartridges and combination product manufacturing. This role will be instrumental in leading the implementation and upgrades of the data historian system and components, in conjunction with MES deployment, to enhance data collection, analysis, and reporting for industrial applications.

Requirements

Bachelor’s degree in Engineering, Computer Science, Information Technology, or related technical field.
Minimum of 5 years’ experience with Data Historian systems (system architecture, PI Server, Asset Framework, DataLink, etc)
Experience in Pharmaceutical or regulated manufacturing environments
Hands-on experience implementing and integrating historian systems with MES, SCADA, PLCs, and other automation systems.
Proficiency with SQL databases and querying tools.
Familiarity with data visualization/reporting tools (Power BI)
Ability to configure data tags, interfaces, and connectors between equipment and historian systems.
Ability to troubleshoot data gaps, interface issues, and communication errors between equipment and historian platforms.
Strong knowledge of GMP, data integrity, and validation requirements
Familiarity with project implementation methodologies in manufacturing IT
Strong command of MS Office applications, including Excel and PowerPoint.
Flexible to support international travel 5-10% of the time
Strong written and verbal communication skills.
Ability to work independently and within teams.
Strong presentation skills.

Nice To Haves

Familiarity with ALCOA+ principles for data integrity is considered an asset.
Bilingual in French and English considered an asset.

Responsibilities

Assist in leading the implementation and subsequent upgrades of the data historian system and components in conjunction with the MES deployment.
Design and configure historian and middleware architecture for data collection from automation equipment (including PLCs), SCADA, and MES.
Develop interfaces and data flows between process control systems, MES, and historian platforms.
Collaborate with stakeholders to define data requirements, tag structures, and data retention strategies.
Ensure compliance with GMP, GAMP, and FDA 21 CFR Part 11 for data integrity and system validation.
In collaboration with the Data & Analytics team, maintain good data governance, and support data analysis, reporting, and visualization tools for real-time and historical insights.
Support the extension of the historian to other sites and industrial use cases as determined by Septodont’s digital committees.
Participate in FAT, SAT, and validation activities for the historian system.
Administer historian and middleware systems globally, including managing access and user rights.
In support of the global EBR team, provide technical support and troubleshooting during execution of projects as well as post-go-live run operation.
In partnership with the IT Cyber Security team, ensure the system is implemented and maintained according to cyber security policies and best practices.
Document system configuration, user requirements, and operational procedures.
Train end users and ensure knowledge transfer to operations and support teams.
Develop skills and knowledge around MES software to support as needed.