Validation Associate II
927 S Curry Pike Bloomington, IN 47402 Bloomington, IN 47402 US
Target Pay Rate: 90-100k **salary will be commensurate with experience
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
- 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
- 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
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