Systems Engineer - LanceSoft Inc
Hillsboro, OR 97124
About the Job
Onsite in Hillsboro, OR - possibility of some/minimal remote work after training is complete.
Mission:
This position, based in ***'s Hillsboro, Oregon facility, provides the opportunity to have 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. The candidate will report to the local IT OT organization, 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 Aseptic filling for Drug Product 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.
What you ll be working on:
Active involvement in the daily operations for all Manufacturing IT OT systems to support the system owners for all Manufacturing systems and supporting the team in manufacturing site projects and with various administrative tasks.
This include activities like:
Troubleshoot immediate DeltaV(DCS) issues, inquiries and Syncade MES inquiries as they arrive during normal business hours.
Update System lifecycle documentation, as the need arises, for both PCS and MES.
Help perform MILE (system maintenance) activities for PCS and MES
Work with cross-functional team for thin client (P&F BTC22) requalification
Perform System periodic reviews- This entails performing data collection from our deviations database on the past 3 year s worth of planned and unplanned events, review impact on system s validated state and draft reports.
Daily/weekly system monitoring for PCS and MES
Attend coordination meetings with different groups within the organization to keep up with changes to global IT systems that may affect MES and PCS.
(e.g. Single LIMS coordination meetings, ST300 Meetings)
Support System Owner squad in the overall procurement, development, integration, modification, operation, maintenance, and retirement of PCS and MES.
Support validation activities
Responsibility for the Periodic System Audit Trail Review
Perform annual automation account review
User account auditing, provisioning, resets and activation for all IT and OT systems
Creating reports for various systems on demand
Work with the System Owners and Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance.
Review ServiceNow tickets and either address them or route them to the SME
Run monthly site termination report and updates to AD
Support on documents management systems (Veeva, Condor, eVal Roche)
Support the team with administrative tasks
Role Minimum Requirements
Education
Minimum Bachelor s degree in Computer Engineering, Automation Engineering or similar
Minimum 5 years of experience in system and/or network administration
Competencies
Management skills
Attention to details and good problem-solving skills
Demonstrated ability to think and solve problems at a system-level
Ability to work and interact productively with stakeholders from different technical domains
Ability to multi-task with a calm behavior and work under pressure in a fast-paced environment
Good team player, self-confident, motivated, and independent
Good communication skills
Technical skills
DeltaV (DCS) Administration
SQL Database Server proficiency. Knowledge with SQL Database Cluster (Always ON), is a plus.
Troubleshooting DCS (hardware and software), MES, web service issues.
MES (Syncade preferred) or other MES platforms
Knowledge of ASP .net web services
Network Administration
Experience with industrial data and control interfaces, preferably OPC and OPC-UA
System administration, supporting multiple platforms and applications
Biopharmaceutical or similar Manufacturing domain knowledge.
Application Engineering experience with manufacturing control systems in a highly automated manufacturing environment, preferably Distributed Control Systems (e.g. DeltaV),
Keep abreast of key Manufacturing IT trends and be curious - Smart Buildings, Smart Manufacturing, Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data Integrity principles, technology, and data standardization, etc.
Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11,cGMP Annex 11, Data Integrity principles.
Entrepreneurial mindset e.g. "automating automation"
Mission:
This position, based in ***'s Hillsboro, Oregon facility, provides the opportunity to have 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. The candidate will report to the local IT OT organization, 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 Aseptic filling for Drug Product 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.
What you ll be working on:
Active involvement in the daily operations for all Manufacturing IT OT systems to support the system owners for all Manufacturing systems and supporting the team in manufacturing site projects and with various administrative tasks.
This include activities like:
Troubleshoot immediate DeltaV(DCS) issues, inquiries and Syncade MES inquiries as they arrive during normal business hours.
Update System lifecycle documentation, as the need arises, for both PCS and MES.
Help perform MILE (system maintenance) activities for PCS and MES
Work with cross-functional team for thin client (P&F BTC22) requalification
Perform System periodic reviews- This entails performing data collection from our deviations database on the past 3 year s worth of planned and unplanned events, review impact on system s validated state and draft reports.
Daily/weekly system monitoring for PCS and MES
Attend coordination meetings with different groups within the organization to keep up with changes to global IT systems that may affect MES and PCS.
(e.g. Single LIMS coordination meetings, ST300 Meetings)
Support System Owner squad in the overall procurement, development, integration, modification, operation, maintenance, and retirement of PCS and MES.
Support validation activities
Responsibility for the Periodic System Audit Trail Review
Perform annual automation account review
User account auditing, provisioning, resets and activation for all IT and OT systems
Creating reports for various systems on demand
Work with the System Owners and Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance.
Review ServiceNow tickets and either address them or route them to the SME
Run monthly site termination report and updates to AD
Support on documents management systems (Veeva, Condor, eVal Roche)
Support the team with administrative tasks
Role Minimum Requirements
Education
Minimum Bachelor s degree in Computer Engineering, Automation Engineering or similar
Minimum 5 years of experience in system and/or network administration
Competencies
Management skills
Attention to details and good problem-solving skills
Demonstrated ability to think and solve problems at a system-level
Ability to work and interact productively with stakeholders from different technical domains
Ability to multi-task with a calm behavior and work under pressure in a fast-paced environment
Good team player, self-confident, motivated, and independent
Good communication skills
Technical skills
DeltaV (DCS) Administration
SQL Database Server proficiency. Knowledge with SQL Database Cluster (Always ON), is a plus.
Troubleshooting DCS (hardware and software), MES, web service issues.
MES (Syncade preferred) or other MES platforms
Knowledge of ASP .net web services
Network Administration
Experience with industrial data and control interfaces, preferably OPC and OPC-UA
System administration, supporting multiple platforms and applications
Biopharmaceutical or similar Manufacturing domain knowledge.
Application Engineering experience with manufacturing control systems in a highly automated manufacturing environment, preferably Distributed Control Systems (e.g. DeltaV),
Keep abreast of key Manufacturing IT trends and be curious - Smart Buildings, Smart Manufacturing, Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data Integrity principles, technology, and data standardization, etc.
Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11,cGMP Annex 11, Data Integrity principles.
Entrepreneurial mindset e.g. "automating automation"
Source : LanceSoft Inc