Primary responsibility is to provide / lead validation services required for the successful delivery of IT & Automation projects.
Provide validation & technical support through the preparation, execution, data analysis, & report writing for IV, OV & PV protocols.
Ownership of Change Requests (CR’s) related to project validation responsibilities.
Perform compliance & technical reviews / approvals of protocols & protocol data.
Author project quality masterplans (PQMP’s), validation plans (VPL’s), & other key validation documentation.
Author & execute assigned IV, OV & PV protocols for direct impact systems / processes per approved timeframes. Requires no guidance & direction to complete these goals & needs no coaching on technical competencies for goal obtainment.
Serves as a source of expertise in the group for validating new systems.
Ensure compliance of validation protocols executed are aligned with local, corporate & regulatory regulations.
Lead validation failure investigations & non-conformities utilizing root cause analysis techniques.
Create & modify existing validation procedures & configuration item lists (CIL’s) as required.
Write / Review specifications, procedures, & other required supporting documents to maintain the validated state of equipment & processes.
Participate in FAT, SAT commissioning efforts for equipment, automation systems & processes & successfully transition into the ownership role for validation efforts related to the equipment.
Identify process improvements before equipment, systems or processes are placed under change control during validation.
Budget oversight as needed.
Contractor scheduling & oversight as needed.
Leads validation activities assigned by overall project manager.
Other accountabilities, as assigned.
Validation Specialist
Author project quality masterplans (PQMP’s), validation plans (VPL’s), & other key validation documentation. Primary responsibility is to provide/lead validation services required for the successful delivery of IT & Automation projects. Provide validation & technical support through the preparation,...
LL01-062824 Validation Specialist
Validation & Engineering Group, Inc. V&EG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other ...
Validation Specialist I/II, Senior Validation Specialist I
Validation Specialist I is responsible for conducting validation studies in accordance with current industry standards and guidelines for the qualification and validation of manufacturing systems and supporting processes. Write protocols, reports and validation master plans and assembles final valid...
Product Quality Validation Specialist
Ensuring that the product conforms to all Critical Quality Attributes (CQAs) and meets all Critical Process Parameters (CPPs) at all stages of the manufacturing process during tech transfer and validation. Create, revise, review, and approve validation protocols impacting the product. Conduct period...
QA Technical Specialist, Validation
Provide Quality technical expertise, Quality oversight, and be a single point of Quality contact for commissioning, qualification, and Validation related activities, to include equipment and instrument qualification, cleaning validation, and/or computer software validation. Site Quality Engineering ...
Validation Specialist
Proven experience as a Validation Specialist, Validation Engineer, or similar role, with a focus on computer system validation. The Validation Specialist will be responsible for the validation of computer systems and processes, ensuring compliance with regulatory requirements. Validation Processes t...
LL01-062824 Validation Specialist
Validation & Engineering Group, Inc. V&EG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services...
Software Engineer (ONTAP Systems C++)
Member of a software engineering team involved in development & design of the features related to AI/ML for NetApp’s flagship storage operating ONTAP. Software engineers focus on enhancements to existing products as well as new product development. This is a mid-level technical position that require...
Systems Engineer
Responsibilities for the Systems Engineer. Requirements for the Systems Engineer. Compensation and Benefits for the Systems Engineer. Assisting with the accreditation process of the systems. ...
Process Engineer
Manage and lead Engineering projects at the Durham site. Ensure required Engineering support and oversight for the manufacture and packaging of the BACT/ALERT product line are available to meet or exceed production targets and quality. Provide direct leadership for business-critical projects includi...