Stark Pharma is hiring: CQV Validation Visual Inspection Specialist in New York

CQV Validation Visual Inspection Specialist

Job Title: CQV Validation Visual Inspection Specialist

Location: Albany, NY

Experience: 3-5 years

Overview

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.

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

• 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.