Job Title: Technical Systems Validation Specialist.
In a highly regulated pharmaceutical environment, ensuring the integrity of computerized systems is crucial for maintaining compliance and quality. We are seeking an experienced CSV engineer to join our team and contribute to the development and implementation of effective validation strategies across manufacturing, packaging, and laboratory environments.
This role requires strong technical expertise in validating GMP-regulated systems, as well as excellent collaboration skills to work with cross-functional teams including Quality, Engineering, IT, and project teams. The ideal candidate will have hands-on experience executing CSV lifecycle activities from preparation through approval of documentation (Validation Plans URS Risk Assessments IQ OQ PQ Reports), supporting risk-based validation approaches for new and existing systems Ensure CSV activities comply with cGMP GAMP 5 Annex 11 CFR Part 21
Responsibilities include executing CSV activities for MES DCS SCADA automated equipment prepare review support approval qualification documents Support project teams aligning validation activities timelines Participate in valuation risk assessments defining testing scope Review system specifications design installation records qualifications Perform periodic reviews assist identifying gaps Maintain SOPs Assist regulatory inspections internal audits Collaborate global/local csv working consistent execution Escalate potential issues senior leads Follow safety procedures commissioning operations requirements include Bachelor's degree relevant field solid knowledge CS regulations Exp extensive industry human professional active communication ESG-leaning growth vision company everyone clear goal straightforward accreditation guidance.
Detailed Responsibilities