Validation Engineering Manager | LS Solutions Inc. | Princeton, New Jersey, United States
Over 12 years of focused experience in Life Sciences industry with emphasis on Validation per US FDA regulations. Excellent working knowledge of US FDA predicates (specifically 21CFR Part 11/210/211/820) as well as industry guidelines including but not limited to GAMP 5.
Areas of Expertise
Ø US FDA regulations and guidelines for Life Sciences GxP Systems implementation and validation.
Ø Lab Instrument and Computer Systems Validation SME, Technical Writer, Quality SME.
Ø Pharmaceutical, Medical Device and Bio-tech Industries.
Ø Project Leadership, Setting Strategy and Goals
Ø Resource Management
Ø Risk Based Approach
· Proficient in providing project leadership and direction in the implementation of GxP systems for Life Sciences.
· Expert in working with clients to set strategy and goals.
· Adept at staying current with FDA regulations, trends and technologies influencing Life Sciences in general.
· Experience in authoring end to end validation project deliverables such as Validation Plan, Requirements Specification (User/Functional), Qualification Protocols (IQ, OQ, PQ), Traceability Matrix, Validation Summary Report & SOPs.
Validated a wide array of systems including Veeva Clinical Vault (eTMF, CTMS, CDMS), SAP, Oracle EBS, Oracle Identity Management (OIM), Oracle Agile Product Lifecycle Management (PLM), NetSuite, ETQ Reliance, Teamcenter, LIMS, TrackWise (CAPA,