SysMind Tech
Validation/Test Lead
SysMind Tech, Boston, MA, United States
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