Trinity Consultants - Advent Engineering · 16 hours ago
Automation CSV Engineer
San Francisco Bay Area
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. The successful candidate will support a complex automation system migration project, leading CSV and automation activities while collaborating with cross-functional teams.
ConsultingInformation TechnologyLegal
No H1B
Hiring Manager
Ana Bonilla
Responsibilities
Lead and execute CSV and automation activities for PCS/MES system migration projects
Support implementation, migration, commissioning, and validation of:
PCS systems (Rockwell, Honeywell)
MES systems (PharmaSuite, POMSnet)
SCADA and PLC platforms
Author, review, approve, and execute CSV lifecycle documentation, including:
Validation Plans
Risk Assessments
Test Protocols (IQ/OQ/PQ)
Traceability Matrices
Validation Summary Reports
Ensure compliance with SDLC, 21 CFR Part 11, Annex 11, Data Integrity, and GAMP 5
Manage and document software changes throughout the SDLC per site procedures
Support programming, configuration, commissioning, and validation of Rockwell and PharmaSuite platforms
Collaborate with automation, IT, QA, and manufacturing teams
Support troubleshooting, root cause analysis, and deviation investigations as needed
Communicate effectively with stakeholders at all levels
Qualification
Required
8+ years of experience in CSV and Automation within a regulated biotech/pharma environment
Hands-on experience with implementation, migration, and validation of:
PCS (Rockwell and/or Honeywell)
MES (PharmaSuite, POMSnet)
SCADA/PLC systems
Strong, hands-on expertise with Rockwell and PharmaSuite (required)
In-depth knowledge of:
SDLC
21 CFR Part 11 / Annex 11
Data Integrity
Computerized System Validation (CSV)
Ability to work independently and collaboratively in team environments
Excellent verbal and written communication skills
Preferred
Familiarity with S88 Batch Standard
Experience with Rockwell software object development
MES recipe authoring and testing experience
Experience with Kneat
Company
Trinity Consultants - Advent Engineering
ADVENT provides a wide array of services supporting the entire phase of the product lifecycle - from conceptual design through production.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Ravi Baliga
CEO
Liz Wilson-SHRM CP
HR Business Partner, Life Sciences
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