GxP Validation Engineer/Analyst (Lab Equipment)

Responsibilities:

· Provide support to the QC Analytical department for activities required to maintain CGMP status of QC Instrumentation hardware and software and to perform comparability studies for the implementation of analytical assays on new instrumentation. This scope includes QC Instruments (both portable and computer-controlled).

· Authoring Corrective & Preventive Action plans (CAPAs) for systems with long-term remediation activities, and authoring final reports for systems with short-term/completed remediation

· Performing supporting remediation work in the form of SOP revisions

· Executing change controls and validation test plans/protocols when required per remediation plans

· Responsible for the development and execution of general deliverables, such as Risk Assessments, Validation Plans, Change Impact Assessments, Design Specifications, User Requirements, Functional Requirements, Configuration Specification, Requirement Trace Matrices, IQ/OQ/UAT/PQ Protocols, and Summary Reports.

Desired Skills and Experience:

· Author, maintain, revise, and/or approve of the Validation Plan.

· Lead the resolution of deviations noted during protocol execution.

· Manage and approve vendor’s documentation as appropriate.

· Ability to impact and influence people/areas in matters related to Validation and GxP compliance.

· Ability to work in a fast-moving dynamic small company environment.

· Ability to mentor junior team members.

· Experiences in other validation areas which may include CSV qualification and Facility Equipment and Utility is a plus.

Required Qualifications:

· Validation experience in a biotech/pharmaceutical environment, specializing in Instrument or Computer System Validation

· Bachelor's Degree in Engineering, Life Science or Computer Science is required.

· Excellent working knowledge of process automation and computer system validation concepts, GAMP methodologies, CFR Part 11 Electronic Records and Signatures requirements and latest industry expectations for data integrity.