AdeptSource (Adeptsource Inc)
Senior CSV / Lab Instrument Validation Consultant
AdeptSource (Adeptsource Inc), New York, New York, United States
Sr. CSV / Lab Instrument Validation Specialist
Type of role:
Contract Duration:
12-36+ months Hourly pay rate:
DOE (C2C, W2, or 1099 permissible) Location:
South San Francisco Bay Area (Remote during COVID)
Our customer is seeking a Senior CSV / Lab Instrument Validation Engineer who is well versed in laboratory instrument processes within a pharmaceutical environment. Must have hands-on experience with
Lab Instrument Qualification . You will be primarily responsible for planning, leading, and executing validation efforts for standalone Lab Instrument Software systems.
Must have strong experience in the following:
Responsible for performing validation of laboratory instrumentation by following approved SOPs, GMPs, and all regulatory requirements. Responsible for mapping and bringing consistency to the instrument lifecycle globally, from purchase support to validation and decommissioning documentation. Plan, lead, and execute validation efforts for standalone Lab Instrument Software systems. Develop and execute validation plans according to approved procedures, collate test results, organize data packages, and maintain all validation documentation. Compile and analyze validation data, prepare reports, and recommend improvements. Provide guidance on laboratory instrument processes and suggest improvements to management. Investigate and troubleshoot issues, determining effective solutions. Support change management and manage existing lab systems. Participate in cross-functional project teams with Development, Quality, and other groups. Familiar with FDA guidelines for instrument and software validation. Experience in the pharmaceutical or biotech industry with knowledge of FDA regulations, including 21 CFR Part 11. Self-motivated with good communication, technical writing, presentation skills; detail-oriented, analytical, and a team player.
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Contract Duration:
12-36+ months Hourly pay rate:
DOE (C2C, W2, or 1099 permissible) Location:
South San Francisco Bay Area (Remote during COVID)
Our customer is seeking a Senior CSV / Lab Instrument Validation Engineer who is well versed in laboratory instrument processes within a pharmaceutical environment. Must have hands-on experience with
Lab Instrument Qualification . You will be primarily responsible for planning, leading, and executing validation efforts for standalone Lab Instrument Software systems.
Must have strong experience in the following:
Responsible for performing validation of laboratory instrumentation by following approved SOPs, GMPs, and all regulatory requirements. Responsible for mapping and bringing consistency to the instrument lifecycle globally, from purchase support to validation and decommissioning documentation. Plan, lead, and execute validation efforts for standalone Lab Instrument Software systems. Develop and execute validation plans according to approved procedures, collate test results, organize data packages, and maintain all validation documentation. Compile and analyze validation data, prepare reports, and recommend improvements. Provide guidance on laboratory instrument processes and suggest improvements to management. Investigate and troubleshoot issues, determining effective solutions. Support change management and manage existing lab systems. Participate in cross-functional project teams with Development, Quality, and other groups. Familiar with FDA guidelines for instrument and software validation. Experience in the pharmaceutical or biotech industry with knowledge of FDA regulations, including 21 CFR Part 11. Self-motivated with good communication, technical writing, presentation skills; detail-oriented, analytical, and a team player.
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