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Veg Group

LL02-251022 C&Q Lead - Inspection Lines

Veg Group, Juncos, Juncos, us, 00777

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Career Opportunities with Validation & Engineering Group A great place to work. Current job opportunities are posted here as they become available. 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. Key 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. Commissioning & Qualification Execution

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. Technical Oversight

Serve as

Subject Matter Expert (SME)

for vision inspection and serialization systems. Review and approve: Vision and camera configuration documentation CCIT and reject logic configuration Troubleshoot technical issues and support automation integration with packaging and filling operations. Compliance & Documentation

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. Qualifications

Education

Bachelor’s degree in Engineering (Mechanical, Electrical, Automation, or related field). Experience

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. Preferred

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.

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