Software Validation Support

** Software Validation Support*
* Kelly Services is currently seeking a SW Validation position for one of our top clients in Bridgewater, MA.

+ Kelly Outsourcing Consulting Group Kelly

OCG, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a SW Validation Support  for a long-term engagement at one of our Global clients in Bridgewater, MA.  This role is a full-time, fully benefited position.

+ As a Kelly

OCG employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from.

+ You'll also be eligible for paid time off, including holiday, vacation and sick/personal time.

+ All Kelly

OCG employees receive annual performance reviews.

** As a Software Validation Support placed with Kelly

OCG you will be responsible for the following:*
* ** Position Summary*
* Client is seeking a Software Validation Support Specialist to support software validation activities within a regulated laboratory environment. This role will focus on validation and configuration support for Lab Ware LIMS (v7), documentation updates, procedural change management, and product inspection-related activities. The ideal candidate will have experience working within GMP-regulated environments and possess a strong understanding of software validation and quality documentation processes.

** Remote work is fine however there is a week of training in Bridgewater, MA at candidate's expense.

** Key Responsibilities*
* + Support software validation activities for Lab Ware LIMS v7 and associated laboratory systems.

+ Assist with configuration updates, testing, and documentation related to Lab Ware LIMS enhancements and system changes.

+ Execute and support validation deliverables, including test scripts, protocols, reports, traceability matrices, and validation documentation.

+ Review, revise, and implement procedural changes within controlled documentation systems.

+ Ensure documentation updates comply with company quality standards and regulatory requirements.

+ Support product inspection activities and maintain accurate records in accordance with established procedures.

+ Collaborate with Quality, IT, Laboratory Operations, and Validation teams to support system improvements and compliance initiatives.

+ Assist with change control activities, impact assessments, and implementation of approved system modifications.

+ Maintain compliance with applicable GMP, FDA, and internal quality system requirements.

+ Participate in training and knowledge transfer activities as required.

** Required Qualifications*
* +  
** Bilingual in Spanish.*
* + Bachelor's degree in a scientific, engineering, quality, information systems, or related discipline, or equivalent experience.

+ Experience supporting software validation activities in a regulated environment.

+ Hands-on experience with Lab Ware LIMS Version 7 configuration and support.

+ Experience managing procedure revisions and controlled documentation changes within a quality documentation system.

+ Experience supporting product inspection processes and related documentation.

+ Strong understanding of validation documentation, testing methodologies, and change control processes.

+ Excellent written and verbal communication skills.

+ Ability to work independently in a remote environment while collaborating effectively with cross-functional teams.

** Preferred Qualifications*
* + Experience working within pharmaceutical, medical device, biotechnology, or laboratory environments.

+ Familiarity with GMP, GxP, FDA, and quality system regulations.

+

Experience with electronic document management systems (EDMS) and change management processes.

+ Knowledge of laboratory workflows and LIMS administration.

** Important information:
** This position is recruited by a remote Kelly office, not your local Kelly branch.  Applicants must be legally permitted to work in the United States.

** Why Kelly**  **®**  **?*
* The Managed Solutions practice within Kelly Outsourcing and Consulting Group (Kelly

OCG ® ) is one focus within the full array of Kelly Services® workforce solutions.

Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions…