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The Instrument Validation Specialist will support a diverse variety of Quality Control and Manufacturing Instrumentation, including analytical and microbiological instruments, maintaining the validated state of the instruments from implementation through their full lifecycle. This role will be responsible for developing validation documentation, including validation plans, requirement specifications, IOPQ protocols, and validation summary reports, execution of validation protools, resolution of any deviations, and managing the project timeline to ensure timely completion of the validation projects.
The primary position responsibilities are listed below:
Authoring validation documentation (validation plans, requirement specifications, IOPQ protocols, validation summary reports) for analytical and microbiology instrumentation
Participating in Data Integrity and Electronic Records and Electronic Signatures assessments for instrumentation during the validation process
Execution of qualification protocols
Resolution of devitations encountered during validation projects
Managing validation project timelines
Additional activities associated with the validation life cycle for GMP instrumentation
This position will regularly interact with:
Quality Control
Quality Assurance
Andover Production Operations
Engineering Validation and Maintenance
Site Technical Services
Business Technology
Other groups as applicable
The required experience is in the area of validation activities supporting manufacturing and development operating in regulated environment. Candidate is required to be experienced with Pharmaceutical Validation requirements (CFR 211, ICH, Annex 15) and/or Medical Device Validation requirements (CFR 811)
Experience also required:
Background in problem solving
Negotiations
Data integrity principles
Project management/support in a matrixed reporting environment
Investigations and Change Control experience
notes
Hybrid role- some activities can be done remote and other activities must be done onsite
candidate must be able to come onsite when needed/ in local commuting distance
open to relocation candidate but want someone to start ASAP
M-F 1st shift
WebEx interviews
OT possible where needed to meet project milestones
