3129 Verification and Validation Engineer
The Device Development group is searching for an experienced Engineer to provide development and implementation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics.
The candidate should have expertise in (verification) testing, systems and methods qualification & validation, maintenances of Laboratory Equipment, and support other engineering and scientific activities within the device development programs.
The Verification and Validation Engineer will work in the Laboratory Operations group and collaborate across functions (e.g. quality, IT, and vendors) and assist Device Engineers and Laboratory staff in developing practical and thorough solutions to problems, and execute validation activities: method validation, equipment qualification, computer system validation, and method transfer.
This objective will be accomplished by executing the following activities:
Coordinate and execute commissioning and qualification of laboratory equipment and computer systems (e.g. hardware, software, and accessory systems) for use in regulated and non-regulated operations.
Author/ review commissioning and qualification documents throughout system life cycle. This includes deliverables such as user requirements, functional/design specifications, qualification protocol/report, and support documentation (i.e. traceability matrices, SOP, etc.).
Author/ review validation and verification protocols documents to support device development deliverables such as protocols/ reports, test methods, and risk assessments.
Execute/ lead test method validation, design verification, and method transfer as required by the lab/projects.
Develop/review/ validate physical test methods to support the selection, design verification, commercialization and marketing of various new combination devices.
Design test fixtures and perform First Article Inspections.
Support procurement and installation activities when needed to ensure proper systems startup and recommend changes to improve system design.
Execute characterization testing to support the selection, design verification, commercialization and marketing of various designs.
Regularly interact with external development partners and equipment suppliers, Quality, and IT group.
Understand, implement and maintain the Pharma Quality Policy and Pharma Quality System (PQS) in the department.
Use (and create and implement, if necessary) local procedures and templates ensuring alignment with current versions of PQS documents and best practices.
Support the laboratory lead in preparing communications for internal review committees.
Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
Create and review discrepancy, change/risk management documents as appropriate.
Ensure compliance of training to PQS and job-related requirements.
Utilize electronic document archive system and collaborate with Records Management team to ensure document compliance with PQS standards and DHF regulations.
Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.
Knowledge of FDA regulations and knowledge of 21 CFR Part 11.
Experience in developing and building (test) fixtures, drawing, and CAD/ SolidWorks.
Knowledge/experience of qualification requirements and procedures for laboratory instrumentation.
Knowledge of Measurement System Analysis (MSA) and statistical data analysis Working knowledge of the development of protocols for validation of instruments.
Knowledge of Design Controls for regulatory compliance & filing (ISO 13485, etc.), GDP/GLP/GMP, Design History Files, Risk Assessments, etc.
Excellent oral and written communication skills Ability to work in a team, highly organized, and detail oriented Six Sigma (Green/Black Belt): DMAIC and DFSS is a plus.
Experience in computer system validation is a plus.
B.S, M.S, or advanced degree in Engineering.
Job level (1 or 2): depends on years of industry experience.