Validation Specialist

2 days ago

Spring Valley, New York, United States Strides Pharma Inc Full time
Job Description

Strides Pharma Inc is seeking a skilled Validation Specialist to join our Engineering Department. As a pivotal member of the team, you will operate both independently and collaboratively to author and execute IQ/OQ/PQ protocols, engineering studies, and facility qualifications.

Key Responsibilities:

  • Ensure adherence to manufacturing specifications, Good Manufacturing Practices (GMP), and national standards.
  • Author change controls, SOPs, and protocols.
  • Generate and execute validation protocols, and summarize studies to ensure compliance with manufacturer and SPI specifications, with current Good Manufacturing Practices, and national standards.
  • Responsible for confirming all communicated validation plans to applicable management.
  • Provide technical assistance in the form of rationales or validation studies.
  • Responsible for effectively adopting modern validation techniques, current industry practices, risk management principles, science-based approaches, and a strong understanding of processes and equipment.
  • Troubleshoot and resolve issues as needed.

Project Management:

  • Manage multiple projects with competing deadlines.
  • Manage external resources to complete tasks outside SPI's capabilities.
  • Manage approvers of documents and procedures and ensure timely closure of tasks.
  • Manage project-related Change Requests from initiation through closure, including presentation to Change Control Committee.
  • Assist with deviation investigation and identify areas for CAPAs as needed based on root causes.
  • Source and procure equipment, supplies, and other materials as needed.
  • Develop and maintain cross-functional relationships.

Requirements:

  • Bachelor of Science in Engineering or related field preferred.
  • Experience in pharmaceutical, medical device, or biotechnology industries, particularly in validation, QA, or R&D roles.

Knowledge and Skills:

  • Proficiency in FDA regulations, GMP/GLP/GCP, and Lean Manufacturing principles.
  • In-depth understanding of pharmaceutical plant operations.

Physical Requirements:

  • Regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Climb ladders and work in high, precarious places up to elevations of 75 feet.
  • Regularly exposed to work near moving mechanical parts.
  • Exposed to wet or humid conditions.
  • Exposed to outdoor weather conditions.
  • Regularly exposed to high noise environments.
  • Exposed to extremely dusty environments.
  • Exposed to chemicals used in the manufacturing process.

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