Energy Jobline ZR
LL02-251022 C&Q Lead - Inspection Lines in 00777
Energy Jobline ZR, Juncos, Juncos, us, 00777
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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:
Position: C & Q Lead – Inspection Lines 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
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.
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.
If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
#J-18808-Ljbffr
We focus on the Oil & Gas, Renewables, Engineering, Power, and Nuclear markets as well as emerging technologies in EV, Battery, and Fusion. We are committed to ensuring that we offer the most exciting career opportunities from around the world for our jobseekers.
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:
Position: C & Q Lead – Inspection Lines 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
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.
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.
If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
#J-18808-Ljbffr