LL02-251022 C&Q Lead - Inspection Lines

Validation & Engineering Group•Gurabo, PR

65d

About The Position

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: The C&Q Lead Inspection Lines oversees and coordinates all Commissioning and Qualification activities for visual inspection systems used in sterile drug product operations, including both manual and automated inspection technologies. This role ensures equipment, control systems, and supporting utilities are qualified in compliance with regulatory standards (FDA, EMA, Annex 1) and ready for GMP use at site start-up.

Requirements

Bachelors degree in Engineering (Mechanical, Electrical, Automation, or related field).
8+ years of experience in Commissioning & Qualification for pharmaceutical or biotech facilities.
3+ years specific to automated visual inspection or packaging systems.
Experience in aseptic operations and data integrity requirements (GAMP 5, 21 CFR Part 11).
Strong understanding of Annex 1 and ISPE GPG: Visual Inspection of Parenterals.
Knowledge of camera systems, vision software, reject mechanisms, serialization, and MES connectivity.
Proficient in using electronic validation tools such as Kneat or ValGenesis.
Skilled in reviewing FAT/SAT documents, IOQ protocols, and risk assessments.

Nice To Haves

Previous experience qualifying inspection lines from Syntegon, Antares, Brevetti, or Seidenader.
Knowledge of CCIT methods (vacuum decay, laser headspace, or HVLD).
Experience in greenfield or expansion projects for aseptic/sterile operations.

Responsibilities

Lead end-to-end C&Q scope for automated and semi-automated inspection lines, including: Vision systems for vial, syringe, and cartridge inspection
Conveyance and reject mechanisms
Integration with MES / SCADA / Serialization systems
Container closure integrity test (CCIT) systems
Develop and maintain the Inspection C&Q Master Plan, aligning with the overall site Validation Master Plan.
Coordinate activities across Engineering, QA Validation, Automation, and Manufacturing Operations.
Establish and monitor C&Q milestones for inspection systems to meet project timelines and regulatory readiness.
Oversee preparation, review, and approval of URS, FAT/SAT, IOQ protocols, and summary reports.
Ensure equipment and vision systems meet GAMP 5, 21 CFR Part 11, and data integrity standards.
Manage vendor FAT/SAT and site integration testing; ensure punch-list closure.
Supervise execution of C&Q protocols in accordance with ASTM E2500 and ISPE Baseline guides.
Maintain traceability between design requirements and executed testing.
Serve as Subject Matter Expert (SME) for vision inspection and serialization systems.
Review and approve: Vision and camera configuration documentation
Control system design (PLC, HMI, SCADA, MES interfaces)
CCIT and reject logic configuration
Troubleshoot technical issues and support automation integration with packaging and filling operations.
Ensure C&Q documentation aligns with GMP, GDP, and corporate validation standards.
Support Quality Assurance during audits and regulatory inspections.
Ensure all deviations, CAPAs, and change controls related to C&Q are properly documented and closed.
Maintain digital records in the validation platform (e.g., Kneat or ValGenesis).
Work closely with Process Engineering, Packaging, and QA Validation to ensure seamless qualification and handover.
Mentor junior C&Q engineers assigned to inspection or packaging areas.
Participate in daily coordination and readiness meetings to track progress and resolve issues proactively.