5509 Validation Engineer II
This position provides support for analytical instrument qualification and validation for research and early phase drug development.
Position maintains lifecycle of GMP systems for testing of early clinical stage compounds from initial qualification to retirement, including data archival, in addition to numerous R&D systems.
We are seeking a candidate experienced in equipment qualifications with an ability to quickly adapt in order to help us meet the challenges and demands for GxP support in an R&D environment.
For the suitable candidate, the potential for a permanent position can be explored long-term.
Initiate and maintain lifecycle of analytical instruments used in testing small molecules in clinical development.
The lifecycle includes qualification, calibration, PM, archival of data, unplanned event (deviation) management, Data Integrity assessments, and decommissioning of analytical instrumentation.
Create and update cGMP lifecycle documents for analytical instrumentation including Risk Assessments, User Requirements and Functional Specifications, and Protocols (IQ, OQ, CSV).
Execute equipment validations and ensure adherence to internal, national, and international regulatory guidelines for Electronic Records and Signatures, DI, cGMP, FDA 21 CFR Part 11.
Develops strategies to comply with requirements while allowing flexibility on analytical instrumentation to perform research and early stage development activities.
Act as Change Owner for analytical instruments and software.
Act as department Subject Matter Expert for the EVal (Valgenesis) system.
Work with equipment owner to recommend appropriate user roles/privileges, revise SOPs, and set up appropriate maintenance.
Complete periodic review of laboratory instruments, software, and documents.
Ability to analyze challenges and adapt to meet changing needs of R&D labs with GMP activities.
Experience in the qualification, calibration, maintenance of GMP instrumentation including, but not limited to, HPLC, GC, LCMS, KF, disso, ICP-OES/MS, and FTIR.
Familiarity with instrumentation strongly desired.
Experience with laboratory software including Empower,Tiamo, Omnic, etc.
History of assessing data integrity requirements.
Demonstrated ability to negotiate risk-based equipment validation with Quality.
Ability to manage multiple activities and adjust priorities as needed.
Strong computer, technical, leadership, and organizational skills and a history of orchestrating tasks through multiple people to accomplish the work.
Excellent communication (oral and written), attention to detail; excellent project management skills including the ability to manage project resource requirements (material, personnel, time, etc.), and ability to communicate and elevate relevant issues to appropriate leadership.
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
Ability to work independently and collaboratively.
Bachelor’s degree in science or engineering.
Experience 3 years qualifying laboratory systems with computers.
Experience 3 years generating laboratory equipment lifecycle documents.
Strong critical thinking and problem-solving skills; self-motivated, adaptable, and positive attitude
Background with GxP and R&D.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.