Analyst I - Operations-Validation Engineer (Kneat-Ops)

Role Description Job Description - Operations Support Specialist Job Title Operations Support Specialist Function Digital Platform Operations Support

Experience Required Overall 3-7 years of experience in regulated GxP environments, Digital platform support, or Digital validation system support Primary Focus Operational support, user coordination, issue tracking, documentation support, and stakeholder follow-up, Performs related duties to support business teams Job SummaryWe are looking for an Operations Support Specialist to support the day-to-day operational management of the Digital Validation platform (Preferably Kneat) in a regulated environment. This role is intended as a support position to the Kneat Operations Specialist, with focus on execution support, service coordination, user-facing follow-up, and operational documentation rather than overall platform ownership. Required Skills and Experience Understanding of regulated GxP / GMP environments and controlled system support processes. Experience in Kneat platform support, validation system support, business system coordination, or comparable operational support roles. Knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity expectations is preferred. Key Responsibilities Support day-to-day platform operations for Kneat, including governance activities, user requests, access coordination, and routine follow-up actions. Support administration oversight activities by coordinating with administrators on access, configuration follow-up, and service continuity matters. Track support tickets, incidents, requests, deviations, and escalations and ensure timely follow-up in line with agreed SLAs. Assist with audit and inspection readiness by organizing documentation, supporting evidence collection, and helping coordinate responses. Coordinate with Quality and IT stakeholders on routine operational issues, periodic reviews, compliance actions, and change-related follow-up. Support user communication, reporting, and updates related to platform usage, support status, and operational priorities. Identify recurring issues or trends and escalate them appropriately to the Operations Specialist or relevant support teams. Help ensure that platform operations remain aligned with business needs, compliance expectations, and defined support processes. Consistent support for stable and compliant platform operations

Skills operations management,cfr part 11,operational support,data integrity,issue tracking,systems support,ticketing,