Join Our CSV Team!

This is a full-time on-site role for an Automation CSV Lead. The Automation CSV Lead will be responsible for the planning, execution, and documentation of Computer System Validation (CSV) activities across GxP systems for Omni clients. You will ensure that all computerized systems meet applicable regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11) and internal quality standards. This role involves the design, development, and implementation of process control systems for pharmaceutical manufacturing, collaborating cross-functionally with IT, QA, and manufacturing teams to ensure systems are validated and maintained in a compliant state.

Logistics:

• Location: On-site project locations.
• Project Scope: Support for next-generation manufacturing technologies and advanced data collection platforms.

• Experience: Minimum 7+ years of experience in CSV, compliance, or QA roles within the pharmaceutical or biotech industry.
• Education: Bachelor’s or Master’s degree in Engineering, Computer Science, Life Sciences, or a related technical field.
• Mandatory Technical Depth:
  In-depth knowledge of GAMP 5, 21 CFR Part 11, Annex 11, ICH Q9/Q10, and data integrity principles.
  • Experience with a vast array of DCS, PLCs, Data Historians, and Alarm Notification Systems (e.g., Delta Controls, OSIsoft Pi, Siemens, Ignition).
  • Proven experience with ERP, LIMS, MES, QMS, and cloud-based systems in a regulated environment.
  • Understanding of IT infrastructure and networking, including VMs, servers, firewalls, and switches.
  • Familiarity with Computer Software Assurance (CSA) principles and risk-based validation methodologies.
• Commissioning & Validation:
  Lead the planning and execution of validation activities for facility, utility, and manufacturing related control systems.
  • Support programming, configuring, and software/hardware lifecycle management.
  • Experience with manufacturing processes such as filtration skids, chromatography, and bioreactors.
• Documentation:
  • Extensive experience developing and maintaining validation master plans, risk assessments, and protocols (IQ/OQ/PQ).
  • Ability to produce and update electrical drawings, control panel layouts, and other technical documentation.
  • Experience writing, reviewing, and updating design and functional specifications (URS, FDS) and technical reports.
• Project Management:
  Proven ability to lead department-assigned control system projects, managing resources and schedules.
  • Experience driving continuous improvement projects alongside capital projects.
• Skills: Excellent technical writing and verbal communication skills; proficiency in MS Office Suite and SQL.

Applicants please contact the following e-mail the following to submit resumes and for inquiries on the job posting: recruiting@omniconsultingservice.com