Quality Engineer

3 weeks ago

Richmond, United States PSRTEK Inc Full time

Role - Quality Engineer - Laboratory Instrument Validation

Location - Bioanalytical Lab, 2240 Dabney Rd, Richmond, VA 23230

Onsite (4 days a week)

Qualifications

Bachelor's degree in a science or engineering related discipline with knowledge in quality operations laboratory processes

7-9 years of experience in the validation of laboratory instruments including those with computerized systems attached in a cGMP environment (required) 7-9 years of experience in the Pharmaceutical industry or relevant business experience within Quality Assurance or Validation cGMP Compliance

Hands on experience operating instrument systems

Demonstrated attention to detail Good oral and legible written communication skills

Must be able to work independently Mastery of core computer software/systems (Word, Excel, Sharepoint, etc.)

Demonstrated ability to work in a team environment and manage workload to meet deadlines

Mathematical and scientific reasoning ability

Responsibilities -

Serving as validation representative for instruments

Partnering with the laboratories, quality system administrators, BT, instrumentation and quality on implementing new instruments at the site

Performing analytical instrument validation including computerized system validation if applicable

Performing any validation change control during the life-cycle of the system

Performing system periodic review Performing system decommissioning

This position will be responsible for providing end-user support for all Quality Laboratory groups as well as compliance to global and site internal policies and procedures

Initiates and leads change control for implementation of new instruments or changes to existing analytical instrumentation and associated instrument control software where applicable in Quality Control laboratories

Authors cGMP risk assessments, user requirements & functional specifications, validation plans, protocols (i.e IQ, OQ, PQ), reports, addendums and other validation deliverables as required by the site validation SOPs

Assist the system owner with evaluating recommending the appropriate user roles and privileges for data integrity (where applicable), writing instrument operation instructions and preventive maintenance plans

Ensures lab instrument's adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA guidelines

Authors protocol to challenge the main aspects of these requirements during validation to demonstrate adherence

For systems found unable to fully comply, formulate workarounds/strategies with core stake holders to mitigate the gaps

Initiates and leads risk assessment, gap analysis, and deviation management associated with validation of lab instruments

Completes periodic reviews of instruments and instrument control software with focus on change control, deviation investigations, and CAPA to ensure compliance and validated state of the instrument

Reviews validation deliverables created by others for adherence to site validation SOPs and acts as validation approver as needed

All other duties as assigned

Position interacts with laboratories within the Quality unit and impacts their compliance and continuous improvement

Other functions key to the instrument validation process include Laboratory System Administrators, Calibration and Documentation #J-18808-Ljbffr

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