4 Computer System Validation (CSV) Engineers to lead 4 teams of CSV Specialists
Locals required for hybrid-onsite (1st week will be onsite for onboarding, training, etc.) Location: Houston, TX - Hybrid / On-Site as Required
Duration: 36 months+
Experience Required: Minimum 10 Years
Target Skills: Kneat validation software, DeltaV Distributed Control Software (DCS) and Rockwell PLC Position Overview Seeking experienced
CSV Leads and CSV Area Leads to support a large-scale pharmaceutical manufacturing project in Houston, Texas.
These positions will lead computer system validation activities for automation and computerized systems across a new pharmaceutical manufacturing campus, including small molecule manufacturing, oligonucleotide production, central utilities, laboratory, warehouse, and supporting infrastructure.
The ideal candidates will have extensive pharmaceutical CSV leadership experience, strong technical knowledge of Emerson DeltaV and Rockwell PLC systems, and a proven ability to manage validation teams, deliverables, schedules, and compliance requirements throughout the project lifecycle.
Key Responsibilities - Lead and manage CSV activities across assigned manufacturing areas, automation systems, and project workstreams.
- Develop and execute CSV strategies, Project Validation Plans, system-specific Validation Plans, and Test Plans.
- Manage CSV engineers, validation specialists, and technical writers to ensure timely completion of project deliverables.
- Oversee the preparation, review, approval, and execution of validation documentation, including requirements, functional specifications, risk assessments, traceability matrices, and qualification protocols.
- Provide CSV leadership for Emerson DeltaV DCS, Rockwell PLCs, vendor-packaged equipment, and integrated manufacturing automation systems.
- Ensure validation activities comply with GMP, GAMP 5, 21 CFR Part 11, EU Annex 11, and Computer Software Assurance (CSA) principles.
- Oversee electronic validation documentation and testing activities using Kneat.
- Collaborate with automation engineers, system integrators, Quality Assurance, manufacturing teams, and project management to coordinate validation activities.
- Review automation design documentation, software configurations, control strategies, and testing deliverables for compliance with validation requirements.
- Lead validation risk assessments, discrepancy investigations, deviation management, change control, and resolution activities.
- Ensure appropriate validation of data integrity, audit trails, access controls, electronic records, backup/recovery, and system interfaces.
- Coordinate validation activities involving DeltaV, PLC systems, PI Historian, MES interfaces, and supporting OT infrastructure.
- Develop and maintain validation schedules, resource plans, progress reports, and project performance metrics.
- Identify potential schedule risks, resource constraints, and compliance gaps, implementing corrective actions as needed.
- Provide technical guidance and mentoring to CSV engineers and other project personnel.
- Support commissioning, qualification, regulatory inspection readiness, and final system handover for GMP operations.
Required Qualifications - Minimum 10 years of Computer System Validation experience within pharmaceutical or biotechnology environments.
- Demonstrated experience leading CSV activities on large-scale pharmaceutical automation or capital projects.
- Strong experience validating Emerson DeltaV, Rockwell PLCs, or comparable manufacturing automation systems.
- Extensive knowledge of GMP, GAMP 5, 21 CFR Part 11, EU Annex 11, and risk-based validation methodologies.
- Proven ability to lead multidisciplinary validation teams and manage multiple project deliverables simultaneously.
- Experience developing CSV strategies, Validation Plans, Test Plans, risk assessments, and traceability documentation.
- Strong understanding of automation system lifecycle activities, including design, software development, testing, commissioning, and qualification.
- Experience managing validation discrepancies, deviations, change controls, and documentation approvals.
- Strong project coordination, scheduling, reporting, and stakeholder management skills.
- Excellent technical writing, communication, leadership, and problem-solving abilities.
Preferred Qualifications - Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical discipline.
- Experience with Kneat electronic validation software, preferably at a Power User level.
- Experience with Veeva Vault or other electronic document management systems.
- CSV experience with AVEVA PI Historian, FactoryTalk AssetCentre, LogMate, and WIN-911.
- Experience with DeltaV infrastructure, vendor-packaged equipment, and Rockwell PLC integrations.
- Experience supporting greenfield pharmaceutical manufacturing facilities.
- Familiarity with ISA-88, ISA-95, MES integration, and batch control systems.
- Previous experience supporting small molecule or oligonucleotide pharmaceutical manufacturing.
- Experience coordinating CSV activities across multiple buildings, systems, and project workstreams.
Work Location & Travel This position follows a hybrid work arrangement with required on-site attendance in Houston, Texas.
- Detailed Design and Construction: On-site attendance at least once per month, or more frequently as required.
- Commissioning & Qualification: Minimum one week per month on-site, with additional attendance based on project needs.
- CSV Leads are expected to maintain a regular on-site presence whenever practicable.
- Additional travel or on-site support may be required during critical project milestones.
