Note: Not available for C2C
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 and validation activities. This include activities like:
Work to support the ITOT System owners in tasks associated with the lifecycle of the system, ie. maintenance, validation, documentation, testing
Update System lifecycle documentation, as the need arises, for ITOT systems (DeltaV, PI, MES, SCADA, LyoPLus, FIT, Client, WAGIT)
Help perform MILE (system maintenance) activities for ITOT Systems
Perform system periodic reviews- This entails performing data collection from the deviations database on the past 3 year’s worth of planned and unplanned events, review impact on system’s validated state and draft reports.
Attend coordination meetings with different groups within the organization to keep up with changes to global IT systems that may affect ITOT Systems
Support System Owner squad in the overall procurement, development, integration, modification, operation, maintenance, and retirement of ITOT systems.
Support validation activities, generation, approval and execution of validation protocols
Assist System Owners in the Periodic System Audit Trail 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
Support on documents management systems (Veeva, Condor, eVal)
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
System Administration
Network Administration
Experience with industrial data and control interfaces, preferably OPC and OPC-UA
System administration, supporting multiple platforms and applications
Ability create and execute validation on computerized systems
Biopharmaceutical or similar Manufacturing domain knowledge.
Application Engineering experience with manufacturing control systems in a highly automated manufacturing environment.
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"