Job Description

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

Project Leadership & Planning

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
+ 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.
###

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

).
###

Collaboration & Leadership

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

.
###

Technical Competencies

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.