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Commissioning Qualification Technical Lead

PACIV

San Juan

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JOB DETAILS
SKILLS
Automation, Baseline Schedule, Biology, Biotech and Pharmaceutical, Budgeting, Change Control, Change Management, Commissioning, Commissioning - Engineering, Construction Engineering, Construction Management, Cost Control, Cross-Functional, Customer Relations, Document Management, Documentation, Documentation Plan, Drug Manufacturing, English Language, GMP (Good Manufacturing Practices), Leadership, Maintain Compliance, Plan Meetings, Process Validation, Progress Reports, Project Control, Project Tracking, Regulations, Reporting Skills, Safety Compliance, Sales Qualification, Strategic Planning, Team Lead/Manager, Technical Leadership, Vendor/Supplier Management
LOCATION
San Juan
POSTED
30+ days ago
PACIV, a global leader in industrial automation solutions serving the Life Sciences sector, is seeking a CQ Technical Lead to lead Commissioning & Qualification (CQV) activities for process and process support equipment within regulated pharmaceutical and biopharmaceutical manufacturing environments. This role is responsible for planning, coordinating, and executing CQV activities from documentation preparation through system handover, ensuring compliance, safety, schedule, and budget objectives are achieved.

Position Responsibilities / Essential Functions:
  • Lead and manage the full CQV lifecycle: planning, documentation, execution, and handover to the Client USER team.
  • Develop and maintain the overall CQ plan and system-based CQV schedule.
  • Coordinate multidisciplinary teams including engineering, construction management (CM), automation, CSV, vendors, contractors, and operations.
  • Oversee CQV documentation preparation, review, approval workflows, and execution readiness.
  • Manage FAT and SAT support activities.
  • Ensure Mechanical Completion (MC) and Automation readiness prior to CQ execution.
  • Lead daily CQV coordination meetings during execution phases.
  • Manage deviations, change control, punch lists, and system handover activities.
  • Ensure compliance with qualification standards and leverage FAT/SAT documentation where applicable.
  • Oversee HSE compliance, including Safe Start-Up and LOTO readiness.
  • Track project milestones, cost, man-hours, and schedule adherence.
  • Provide progress reporting and support contract/vendor management activities.
  • Support PQ and PPQ activities as required.
Requirements:
  • Knowledge of engineering disciplines, commissioning, compliance, qualification and qualify aspects of biopharma or pharmaceutical manufacturing.
  • Minimum 10 years of experience in Process Commissioning & Qualification (CQV).
  • Strong experience in GMP-regulated pharmaceutical or biopharmaceutical environments.
  • Proven experience leading multidisciplinary CQV teams.
  • Strong understanding of compliance, quality systems, and regulatory expectations.
  • Fluent in English (written and spoken).
Desired Hard Skill Sets:
  • Commissioning & Qualification: System definition and classification, CQ strategy development, FAT/SAT, IQ/OQ support, deviation and change control management.
  • Process Equipment: Commissioning and qualification of process and process support systems.
  • Project Controls: Baseline scheduling, cost control, progress reporting, resource planning.
  • Compliance & Quality: GMP, HSE, documentation management, inspection readiness.
  • Leadership: Cross-functional coordination, vendor management, client-facing communication.

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PACIV

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