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Process Validation Engineer

Company: Rangam Consultants Inc.
Location: Danbury
Posted on: November 24, 2022

Job Description:

Looking for candidates with extensive validation experience -75-80% of the role M-F Normal working hours Process Validation Engineer Job Summary: The Engineer is a key member of the Advanced Operations (AO) engineering team responsible to support the manufacturing design transfer of new products into manufacturing. This position is a 12-month contract position in the Danbury CT office which will work within the AO group to assist with the process validations of New Product Introductions. The individual will work directly with Project Engineers, Test Engineers and Manufacturing Technicians to create technical documentation, lead risk management activities, write and execute manufacturing validations. A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. Normally receives little instruction on day-to-day work, general instructions on new assignments. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Essential Duties and Responsibilities: The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. Develops, writes, and executes process validations (IQ/OQ/PQ) on manufacturing processes and in process test equipment for capital medical device equipment. Develops, writes, and executes Test Method Validations (TMV) on in process tests and inspections. Gives input to the creation of process flowcharts, Risk Files & Process Control plans. Risk management team member to ensure that all Process Risks (PFMEA) are accounted for and proper mitigations are in place. Develops validation methods to account for identified process risks. Acts with urgency to identify, diagnose, prioritize, and resolve project and technical issues as they relate to validations and risk mitigations. Works cross functionally with other departments to represent Operations in the NPI process. Conduct process analyses and use statistical techniques and risk-based decisions to analyze data. Prioritize and leads activities such as process failure reviews, Kaizen events and process enhancement activities aimed at improving quality, reducing cycle time, and reducing cost. Work with Manufacturing to ensure assembly procedures and manufacturing test procedures are validation ready. Create and manage Engineering Change Order documentation including validation data, protocols and reports within 's Quality Management system. Create additional manufacturing documentation as needed to support New Product Introductions. Assist with gathering and documenting equipment and test requirements for components and assemblies. Interact with team leader on project status and resolution of critical issues; Promptly escalate unresolved dependencies and issues, which affect product delivery and quality that are beyond scope of influence. Learn and adapt to QMS and work closely with Engineering cross functional teams Qualifications Education: Bachelor's Degree in Technical Area of Study May have Master's Degree Experience: 2-5 Years of Experience with Bachelor's Degree in Technical Area of Study (somewhat flexible on education/experience). If candidate has extensive experience, but not a completed degree, they may considered. 1-3 Years of Experience with Master's Degree. Skills Required Excellent written and verbal communication skills. Adapts communication style to suite different audiences. Creates precise, accurate technical documentation. Able to facilitate group discussions. Strong knowledge of process validations (IQ/OQ/PQ) in a manufacturing environment preferably FDA regulated Strong knowledge of Good Documentation Practices (GDP) Strong knowledge of Test Method Validations Knowledge of statistical techniques such as process capability (cpk/ppk) and statistical process controls (SPC) Strong contributor to high performing team Advanced knowledge of MS Office Ability to meet project deadlines and fluidly transition between multiple simultaneous projects Beneficial Understanding of medical device compliance, standards, and regulations Working knowledge of manufacturing, quality improvement and cost reduction methodologies such as CIMs, Lean, Root Cause and Root Cause Failure Analysis, SPC and Six Sigma Basic knowledge of SolidworksJob Type: ContractPay: $55.00 - $60.00 per hourBenefits: Dental insurance Health insurance Vision insuranceSchedule: 8 hour shift Monday to FridayAbility to commute/relocate: Danbury, CT 06810: Reliably commute or planning to relocate before starting work (Required)Work Location: One location

Keywords: Rangam Consultants Inc., Danbury , Process Validation Engineer, Engineering , Danbury, Connecticut

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