Validation Engineer

New Albany, OH 43031

Posted: 07/03/2024 Job Number: 39406

Job Description


Validation Engineer


Top 3 Must Have Skill Sets:
  1. Experience with testing tools (ALM, or Kneat or ValGenesis).
  2. Experience with ServiceNow (Change Module), Track wise (CAPA, Deviations, Change), Veeva document management, CAPA, Deviations, Change Management.
  3. Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211.
  4. Understanding of industry standards and best practices for computer system validation such as GAMP 5.

*Must have experience with deviations
*IT infrastructure tools is highly preferred but not required (example: backup and restore, disaster recovery)

Red Flags:
  1. cannot support onsite operations
  2. Overly long or irrelevant resume
  3. Exaggerated or vague job titles and responsibilities
  4. Lack of achievements or quantifiable results

Summary:

Primarily responsible for ensuring adherence to computer validation standards and procedures for computer related systems. Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues.

This role is for a strong background in IT Business systems validation, IT Automation systems validation, ensuring that our Information technology systems and processes meet regulatory requirements and industry standards, particularly within the framework of GxP (Good manufacturing Practice) in projects. Integrates a variety of systems technologies to provide systems related solutions to meet business needs. Supports the creation and maintenance of our computer systems validation.

Responsibilities:
  • Perform Deviations, CAPA, Change records for DTI computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc).
  • Provide support to system owners on completing Design Spec, URS, Traceability, IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) draft copies.
  • Provide support on completion of validation deliverables as required per the project.
  • Develop and execute test scripts in ALM, Kneat test tools to support system owners/IT Application Owners.
  • Ensure and track computer systems periodic reviews and periodic access reviews are completed as per schedule to maintain system maintenance phase.
  • Ensures that systems are maintained in a compliant manner according to the DTI quality systems standards.
  • Support regulatory inspections and internal audits as required.

Basic Qualifications:
  • Master degree
OR
  • Bachelor degree and 2 years of experience
OR
  • Associate degree and 6 years of experience
OR
  • High school diploma / GED and 8 years of experience

Academic/Technical Qualifications:
  • Bachelor’s Degree in a science or Engineering discipline required.
  • 5+ years relevant experience in computer system validation (E.g: MES, SCADA, Building Management system (BMS, QBAS), Serialization, QC systems).

Technical / Knowledge:
  • Experience with ALM or Kneat testing tool is plus.
  • Experience with ServiceNow, Track wise (CAPA, Deviations), Veeva document management, CAPA, Deviations, Change Management.
  • Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211.
  • Understanding of industry standards and best practices for computer system validation such as GAMP 5.

 

Pay range is $28 - $33 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

THE PROMISES WE MAKE:

At Crystal Equation, we empower people and advance technology initiatives by building trust.  Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start.  We will serve to empower you along the way and provide the path for your professional journey.

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About New Albany, OH

Discover exciting job opportunities in the enchanting area of New Albany, Ohio! If you're seeking a vibrant location with endless growth possibilities, look no further. Known for its picturesque landscapes, charming boutiques, and thriving arts scene, New Albany offers a unique blend of small-town charm and big-city amenities. Imagine working just a short drive away from the renowned New Albany Country Club, the McCoy Center for the Arts, and the delicious New Albany Farmers Market. Embrace the chance to be part of a community that values innovation, culture, and a high quality of life. Explore our job listings today and take the first step towards a fulfilling career in this captivating region!