SysMind Tech
Validation/Test Lead
SysMind Tech, Boston, Massachusetts, us, 02298
Relevant Experience
(in Yrs)
10 + years
Technical/Functional Skills
Validation/Test hands on in manufacturing/lab systems in pharma companies. Experience in Waters Empower system
Experience Required
Overall IT Experience: 10 years + Validation Lead/Test Experience: 5 years + Tools sets experience: • Micro Focus ALM (HP ALM) • MS Office tools set Must have Experience: • Should have solid validation lead experience working for pharmaceutical companies as Val lead. • Should have great communication and coordination skills between internal team and customers across shores. • Should have good track record in managing teams to successful project delivery. • Should have solid experience in creating/executing best practices, guidelines, checklist GxP projects execution. • Worked in Life Sciences vertical both GxP and non GxP space. • Familiar with Life science business process flow. • Should have good understanding and experience on execution and managing GxP projects and deliverables. • Experience in systems like
Waters Empower(Must) , LIMS, MES, etc will help.
Roles & Responsibilities
As a hands on Val/Test lead is responsible for end to end validation and testing deliverables following Computer System Validation life cycle and also author, review, approve GxP/Risk Assessment, Val Plan, IQ, OQ, PQ, Val Summary, Traceability matrix, URS, FRS, Design documents
(in Yrs)
10 + years
Technical/Functional Skills
Validation/Test hands on in manufacturing/lab systems in pharma companies. Experience in Waters Empower system
Experience Required
Overall IT Experience: 10 years + Validation Lead/Test Experience: 5 years + Tools sets experience: • Micro Focus ALM (HP ALM) • MS Office tools set Must have Experience: • Should have solid validation lead experience working for pharmaceutical companies as Val lead. • Should have great communication and coordination skills between internal team and customers across shores. • Should have good track record in managing teams to successful project delivery. • Should have solid experience in creating/executing best practices, guidelines, checklist GxP projects execution. • Worked in Life Sciences vertical both GxP and non GxP space. • Familiar with Life science business process flow. • Should have good understanding and experience on execution and managing GxP projects and deliverables. • Experience in systems like
Waters Empower(Must) , LIMS, MES, etc will help.
Roles & Responsibilities
As a hands on Val/Test lead is responsible for end to end validation and testing deliverables following Computer System Validation life cycle and also author, review, approve GxP/Risk Assessment, Val Plan, IQ, OQ, PQ, Val Summary, Traceability matrix, URS, FRS, Design documents