Software Validation Support

Software Validation Support

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

As a Software Validation Support Specialist, 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 LabWare 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 LabWare LIMS v7 and associated laboratory systems.
• Assist with configuration updates, testing, and documentation related to LabWare 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 LabWare 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.