Compliance Validation Specialist

1 week ago

College Station, Texas, United States CPMNA Full time
Job Overview

The Validation Engineer at CPMNA will operate under general supervision, focusing on the creation and implementation of validation protocols for Facilities, Utilities, Systems, and Equipment (FUSE). This role includes the preparation of comprehensive validation reports.

Key Responsibilities:

  • Develop, secure approvals for, and execute validation documentation for FUSE systems and associated infrastructure. This includes Validation Plans, System Impact Assessments, User Requirements Specifications, Risk Assessments, Installation/Operational Qualifications, Performance Qualifications (as applicable), and Validation Final Reports, ensuring compliance with regulatory and procedural standards.
  • Collaborate with Validation Engineers-Specialists and the Validation Manager to plan and coordinate validation tasks across various teams, providing regular updates on validation activities related to routine operations or project initiatives.
  • Work autonomously with minimal oversight from Senior Validation Engineers-Specialists or the Validation Manager, including authoring protocols, executing tasks, analyzing results, and drafting reports.
  • Review all FUSE System Delivery Life Cycle (SDLC) outputs, offering constructive feedback and ensuring adherence to relevant Standard Operating Procedures (SOPs).
  • Update and revise SOPs, forms, templates, documentation, and records as necessary.
  • Conduct all responsibilities in a compliant and ethical manner, adhering to applicable laws, regulations, and industry standards.
  • Perform additional tasks as assigned.

Required Skills & Qualifications:

  • In-depth knowledge of engineering principles.
  • Expertise in FUSE Systems, including Classified Clean Rooms, Clean Utilities, Sterilization Equipment, and Temperature Controlled Units (2-8 C, -80 C, LN2 Freezers, Incubators).
  • Familiarity with ISPE Baseline 5, Vol. 2 – Commissioning and Qualification, as well as FDA industry regulations.
  • Excellent written and verbal communication skills.
  • Proficient in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).
  • Ability to operate with general guidance from Senior Validation Engineers-Specialists or the Validation Manager.
  • Capable of thriving in a fast-paced, innovative research and manufacturing environment.

Working Conditions & Physical Demands:

The physical requirements outlined here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While executing job duties, the employee is frequently required to:

  • Stand for extended periods, with some bending, stooping, and stretching.
  • Utilize hand-eye coordination and manual dexterity to operate office equipment such as keyboards, photocopiers, telephones, and calculators.
  • Regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Work on ladders as necessary.
  • Maintain consistent attendance.

Education & Experience:

  • Master's Degree with two (2) years of direct experience in Validation within the pharmaceutical, biotechnology, or related sectors, preferably in FDA-regulated environments.
  • Bachelor's Degree with four (4) years of direct experience in Validation within the pharmaceutical, biotechnology, or related sectors, preferably in FDA-regulated environments.
  • Associate's Degree with six (6) years of direct experience in Validation within the pharmaceutical, biotechnology, or related sectors, preferably in FDA-regulated environments.

Preferred Qualifications:

  • Degree in an Engineering or Science discipline.

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