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Validation Associate II

Bloomington, IN 47402

Posted: 01/04/2024 Employment Type: Direct Hire/Perm Job Category: Engineering Job Number: 594643 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 90-100k **salary will be commensurate with experience 

Job Description:

The Validation Associate II is a key member of the Computer Systems Validation team within the Technical Services organization. The Validation Associate II must have a working knowledge of the overall requirements dictated by worldwide regulatory agencies with respect to computer systems validation. This position works directly with the Information Technology department and other functional areas and is considered the lead validation resource. The Validation Associate II understands industry best practices and maintains a state of audit readiness always. This position reports to the Manager, Computer Systems Validation.
What you'll be doing:
  • Validation document author/reviewer – VP, URS, FS/DS, TM, IQ, OQ, PQ using established templates
  • Technical writing proficiency – VP, URS, FS/DS, TM, IQ, OQ, PQ using established templates.
  • Entitlement Reviews – Coordinates user access reviews for recertification and authorization
  • Local Change Control owner
  • CSV periodic reviews – to maintain the validated state, the Associate will perform periodic reviews of validation packages per established procedures
  • Validation lead GAMP Category 1 - 4
  • Client audits – The Associate will participate in client audits, responding verbally to auditor’s questions.
  • Global Change Control task owner
  • System assessments – Quality, Regulatory, Risk, Gap
  • CAPA owner
  • NCR/SNCR investigator
  • Validation Lead for implementation of major and minor software applications or modules for Good Manufacturing Practices (GMP) use.
  • Completes detailed risk assessment and 21 CFR part 11 Gap analysis
  • Maintains departmental compliance with regulations and corporate procedures
  • Coordinates computer systems implementation activities with Vendors and other non-BPS resources
  • Creates/Reviews validation documentation, templates, procedures, and all documentation generated during a computer systems validation project
  • Participates in Internal/Client/Corporate Audits
  • Represents validation department as validation expert in cross-functional work teams
  • Advocates and understands best practices for system validations and processes
  • Articulates complex systems and communicates to technical and non­technical management
That you'll bring:
  • B.S./B.A. in a related field (or equivalent experience)
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  ERP, EDMS, QMS, etc.)
  • Experience with Microsoft Project
  • Minimum 3 years’ experience of working within a regulated environment (worldwide regulatory agencies), particularly in computer systems validation or other validation discipline
  • Minimum of 2 years to gain the experience needed to master Validation Associate II responsibilities
Physical / Safety Requirements
  • Duties may require overtime work, including nights and weekends
  • Use of hands and fingers to manipulate office equipment is required
  • Position requires sitting for long hours, but may involve walking or standing for periods of time

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Bloomington, IN

Discover exciting job opportunities in Bloomington, Indiana! Nestled in the heart of the Hoosier State, Bloomington offers a vibrant community, a thriving arts scene with venues like the Buskirk-Chumley Theater and the Eskenazi Museum of Art, and a bustling downtown area filled with charming shops and unique restaurants serving up delicious farm-to-table cuisine. Home to Indiana University, a top-tier educational institution, Bloomington provides endless growth opportunities and a welcoming atmosphere for professionals looking to advance their careers. Don't miss the chance to be part of this dynamic city, explore our job listings today and kickstart your career in Bloomington!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.