CQV Validation Visual Inspection Specialist

Job Title : CQV Validation Visual Inspection Specialist

Location : Albany, NY

Experience : 3 5 years

Job Summary :

The CQV Validation Visual Inspection Specialist is responsible for executing commissioning and qualification (C&Q) activities for visual inspection systems, ensuring compliance with regulatory and company quality standards. This role supports equipment qualification, validation documentation, and execution for manual, semi-automatic, and automatic visual inspection machines used in sterile manufacturing or packaging operations. The specialist ensures inspection systems meet GMP and regulatory requirements to maintain product quality and patient safety.

Key Responsibilities :

Perform commissioning and qualification (IQ / OQ / PQ) for visual inspection systems and related equipment.

Execute validation protocols, collect and analyze data, and document results in compliance with GMP and corporate standards.

Participate in system FAT / SAT, risk assessments, and readiness reviews for visual inspection equipment.

Support the development and execution of validation protocols (URS, DQ, IQ, OQ, PQ).

Ensure equipment and process validation activities comply with FDA, EU, and other global regulatory requirements.

Collaborate with engineering, manufacturing, automation, and quality teams during C&Q and validation phases.

Conduct visual inspection process validation and challenge tests, such as defect kits and detection capability studies.

Identify and troubleshoot inspection system issues and deviations, supporting corrective and preventive actions (CAPAs).

Maintain detailed, accurate, and compliant documentation throughout the validation lifecycle.

Adhere to safety, environmental, and quality policies during all validation activities.

Qualifications and Experience :

Bachelor's degree in Engineering, Life Sciences, or related discipline.

2 5+ years of experience in pharmaceutical / biotech CQV or validation, preferably in aseptic or sterile manufacturing.

Knowledge of visual inspection systems (manual, semi-automatic, automatic).

Understanding of GMP, GAMP 5, and validation lifecycle principles.

Experience with protocol preparation, execution, and report generation.

Strong technical writing, communication, and organizational skills.

Familiarity with applicable regulations (FDA, EMA, Annex 1, ICH Q7 / Q9 / Q10).

Core Competencies :

Attention to detail and commitment to high-quality documentation.

Strong problem-solving and root cause analysis skills.

Effective collaboration and teamwork across functions.

Ability to manage multiple tasks and meet deadlines in a fast-paced environment.

Commitment to safety, compliance, and continuous improvement.