Validation Engineer II
About The Position
An engineering professional that works with project engineers, stakeholders, and other project team members to complete tasks associated with commissioning and qualification of new or modified equipment, facilities, and utilities. The main objective of commissioning is to ensure the safe and orderly handover of the unit from the constructor to the owner, guaranteeing its operability in terms of performance, reliability, safety, and information traceability. When executed in a planned and effective way, commissioning normally represents an essential factor for the fulfillment of schedule, costs, safety, and quality requirements of the project.
Requirements
- Bachelor’s degree in engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 3+ years of significant engineering and/or operational experience.
- A technical background in health care, nutritional products, laboratory diagnostics, medical devices, pharmaceutical, or similar industries (preferred).
- Experience in the development of commissioning and qualification deliverables including specifications and testing protocols that can stand up to regulatory scrutiny.
- Strong interpersonal, communication, and negotiation skills with demonstrated ability to work within a team environment.
- A basic understanding of government regulations such as FDA cGMPs.
Nice To Haves
- Bachelor’s degree in engineering, science or computer science is Highly Desired.
- 3+ years validation experience writing and executing (IQ/OQ/PQ) with systems and equipment on the shop floor is Highly Desired.
- Experience with cGMP in a Pharmaceutical or Medical Device industry is Highly Desired.
- Knowledge of clean validation, temperature mapping, control temperature unit (autoclave and freezer) is Highly Desired.
Responsibilities
- Develop, Execute and Implement Validation Documentation - Specification documents, SOPs, IQ/OQ/PQ equipment validation protocols, re-qualifications, and prepare applicable documents (functional requirements, plans, and final validation reports) to be compliant with applicable regulatory requirements, internal company standards, and industry practices. Technical review of Validation Documents.
- Execution of qualification and requalification protocols including autoclave and control temperature units within the QC Laboratory and Production areas using the Kneat paperless qualification system.
- Independently plans and conducts small to medium size assigned projects across various types of validation/ qualification including facilities, utilities, equipment, and automation systems. Manages multiple, often concurrent, projects and meets deadlines and balances multiple demands
- Process and complete EWR / EIR Records in the CMMS. Support equipment release using the CMMS system and associated procedures.
- Support Quality Investigations (Investigations and Corrective and Preventative actions (CAPA) and collaborating with quality and manufacturing in the root cause verification and corrective action implementation.
- Support site Cleaning Validation program.
- Process and complete work order demand maintenance review and new equipment installation records in the CMMS (Computer Maintenance Management System) according to the site procedures.
Benefits
- paid time off (vacation, holidays, sick)
- medical/dental/vision insurance
- 401(k)
- short-term incentive programs
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
