Systems Engineer - Tailored Management

Job Title: Systems Engineer
Location: 4625 NE Brookwood Parkway, Hillsboro, OR
Duration: 6 months contract possibility of extenstion

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 "