Commissioning/Qualification Validation Specialist

3 weeks ago

Warren, United States System One Holdings, LLC Full time
Job Title: Commissioning/Qualification Validation Specialist

Location: Warren, NJ- Local candidates only

Hours/Schedule: Mon - Fri, Business Hours

Type: Contract

Overview

Leading Pharmaceutical company looking for an experienced Validation Engineer. Ideal candidates should have a minimum of 3 years of experience developing and executing facility and utility qualification.

Responsibilities
  • Commissioning and Qualification:
    • Administer change control activities and corrective and preventive actions.
    • Review, approve, and execute test protocols, validation deliverables, and plans as needed.
    • Author, review, and approve SOPs, work practices, and other procedural documents.
    • Provide input and guidance for change strategy, risk assessment, testing and compliance gaps.
    • Serve as an SME for change controls, investigations, CAPAs, and audits, as applicable.
  • Promotes and provides excellent customer service and support:
    • Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.
    • Provides technical support and guidance on equipment commissioning and qualification. Interfaces with customers to ensure all expectations are met.
    • Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
  • Communication and Management of Timelines:
    • Ensures timely completion of equipment commissioning and qualification projects, individually and/or with support of contracted personnel.
    • Develops an effective mechanism for communicating the current status of all manufacturing and laboratory equipment to affected stakeholders.
    • Continually seeks opportunities to increase internal client satisfaction and deepen client relationships.
  • Regulatory Responsibilities:
    • Ensures manufacturing and laboratory facilities and utilities are maintained in compliance with GMP and other BMS standards and regulations.
    • Acts as equipment commissioning and qualification SME in internal and regulatory audits.
Requirements
  • BS in Engineering required. Must be able to read and understand construction and mechanical drawings and P&IDs.
  • Minimum of 3 years of experience in FDA-regulated industry.
  • Minimum of 3 years of experience developing and execution facility and utility qualification.
  • Strong background and experience in laboratory and manufacturing operations.
  • Knowledge of cGMP in the pharmaceutical industry.
  • Thorough knowledge and hands-on experience in commissioning and qualification of manufacturing facilities: REQUIRED - manufacturing rooms, material path-throughs;
  • Thorough knowledge and hands-on experience in commissioning and qualification of common utilities: REQUIRED - compressed air, carbon dioxide, process air, AHUs; PREFERRED - liquid nitrogen supply systems, DI Water.
  • Thorough knowledge and hands-on experience with airflow visualization (smoke studies).
  • Strong computer skills, knowledge of calibration management and environmental monitoring systems preferred.
  • Experience interacting with external and/or internal auditors in a compliance audit environment with direct interaction including face to face interaction and response to audit questions is preferred.
Skills:
  • AHU commissioning and qualification
  • Airflow visualization (smoke studies)
  • CO2 and Process Air systems qualification
  • Facilities commissioning and qualification


Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

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