Validation Engineer - CSV - Katalyst Healthcares & Life Sciences

Responsibilities:

• 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 Roche).

• Support the team with administrative tasks.

Requirements:

• Minimum bachelor's degree in computer engineering, Automation Engineering or similar.

• Minimum 5 years of experience in system and/or network administration.

• 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 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"