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CSV Validation Specialist

2 months ago

Akron, Ohio, United States Axelon Full time
Job Overview:

This position requires 50% onsite presence.

Work Schedule: Monday to Friday (flexibility in hours may be necessary based on business requirements).

POSITION PURPOSE:

The CSV Validation Specialist plays a crucial role in ensuring the effective deployment of manufacturing and laboratory equipment, as well as computerized systems across multi-use sites. This role involves collaboration with both internal stakeholders and external service providers.

The individual in this position is responsible for achieving key milestones related to equipment qualification and systems validation.

Operating with minimal supervision and guided by general instructions, this professional will execute routine tasks, employing basic analytical skills to identify and resolve common issues of limited scope.

As a developing team contributor, the specialist will engage with their immediate supervisor and colleagues within their work group to meet team objectives while fostering trust and collaborative relationships beyond their immediate team.


ESSENTIAL COMPETENCIES:

Knowledge, Skills, and Abilities:

  • Proficient understanding of MS Windows client and server technologies.
  • Familiarity with standard networking principles and technologies.
  • Comprehensive knowledge of cGXP requirements and effective documentation practices related to systems, equipment, and instrumentation in the pharmaceutical sector.
  • Strong understanding of ISPE guidance and compliance with 21 CFR Part 11.
  • Ability to collaborate with end users to identify and document User and Functional Requirements.
  • Knowledge of laboratory and manufacturing systems within the pharmaceutical industry.
  • Experience in executing equipment qualification documentation.
  • Effective interaction with laboratory, QA, and Facilities teams.
  • Strong organizational skills to manage tasks in a fast-paced environment while monitoring concurrent assignments that may affect timely completion.
  • Excellent written and verbal communication skills, including solid presentation abilities. Proficient in crafting well-structured emails and reports. Capable of following oral and written instructions and interpreting engineering manuals/drawings relevant to assigned tasks.
  • Strong computer proficiency in Microsoft Office Suite, including Word, Excel, Visio, and Outlook, with the ability to learn new software as necessary for equipment qualification.

Core Competencies:

  • Technical / Professional Knowledge
  • Problem Solving / Troubleshooting
  • Action Oriented
  • Attention to Detail
  • Multitasking
  • Relationship Building

EDUCATION AND EXPERIENCE:

  • Required: Bachelor’s degree in Engineering or Computer Science.
  • Minimum of 5 years of experience in an FDA-regulated environment, with at least 3 years focused on CSV.

KEY RESPONSIBILITIES:

Essential Functions:
Ensure all qualified and validated equipment and systems comply with established policies, guidelines, and procedures.

  • Develop protocols and associated reports while adhering to a structured change management process.
  • Assist in executing equipment qualifications and validation protocols.
  • Oversee vendor activities related to qualification functions.
  • Support calibration, equipment qualification, and validation tasks.
  • Configure and document the setup of computerized systems.
  • Generate validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, and Change Controls.
  • Manage projects of varying complexity and scope.
  • Facilitate laboratory and manufacturing equipment implementation projects, including scheduling, procurement, site preparation, installation, qualification, and transition to business operations.
  • Take independent ownership of all lifecycle deliverables in the qualification of equipment and comprehensive CSV for both single and multi-user Computerized Systems.
  • Assist internal customer groups with the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs according to required schedules.
  • Complete all qualification and validation documentation with accuracy, thoroughness, and adherence to company standards.
  • Provide exceptional customer service and support.
  • Regularly assess, prioritize, and respond promptly to customer equipment qualification and support requests.
  • Offer technical support and guidance on calibration and equipment qualification matters, ensuring customer expectations are met.
Maintain positive relationships with all team members and site customers while promoting a collaborative team environment.

WORKING CONDITIONS:

Environmental Conditions:
  • Work may occur in an office or laboratory/manufacturing setting.
  • Ability to operate safely in environments with hazardous, radioactive, and infectious materials and waste.
  • Ability to work safely both independently and collaboratively.

This job description outlines the general nature and level of work expected from the individual in this role. The primary duties and responsibilities are intended to represent essential functions of the position. Additional job-related duties may be assigned as required by management.


Additional Job Requirements:
Laboratory work without blood and animal handling.
Position involves handling hazardous materials.