Stark Pharma Solutions Inc is hiring: CQV Engineer – Visual Systems in New YorkMediabistro • New York, NY, United States
Stark Pharma Solutions Inc is hiring : CQV Engineer – Visual Systems in New York
Mediabistro • New York, NY, United States
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job_description.job_card.job_descriptionBachelor'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). 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.
Overview
Join to apply for the CQV Engineer – Visual Systems role at Stark Pharma Solutions Inc
Job Details
Location : Albany, NY
Experience : 3-5 years
Responsibilities
- Perform IQ / OQ / PQ for visual inspection systems and related equipment.
- Execute validation protocols, analyze data, and document results in compliance with GMP and corporate standards.
- Participate in system FAT / SAT, risk assessments, and readiness reviews.
- Support development and execution of validation protocols (URS, DQ, IQ, OQ, PQ).
- Ensure compliance with FDA, EU, and 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 (defect kits, detection capability studies).
- Identify and troubleshoot inspection system issues and deviations; support CAPAs.
- Maintain detailed, accurate, and compliant documentation throughout the validation lifecycle.
- Adhere to safety, environmental, and quality policies during all validation activities.
Qualifications
Core Competencies
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