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Senior Validation Engineer
2 months ago
Job Summary
:This person will work with the engineering team to develop and optimize manufacturing processes within the company. Key to this role will be to lead a team of engineers/technicians in the specification, introduction, validation and continuous improvement of equipment and processes.This person will be responsible for outlining and developing the business case for investments into the area and then the management and implementation of projects to completion.
Essential Duties and Responsibilities:
Lead a technical team to specify, introduce, validate, and continuously improve equipment and processes. Maintain, improve, upgrade existing processes to maximize safety, quality, and performance Integrate new technology into existing processes supporting continuous improvement Train team members as required on best practices and changes to improve the process Establish and maintain metrics specific and meaningful to process Lead assigned process improvement projects Plan, schedule, or perform projects within the approved time schedules and budgets. Guide, coordinate, or perform modifications, improvements or validations of existing or new formulations/products, processes and equipment Ensure that all projects and activities are in compliance with local, regional and best practice requirements on HSE and meet other applicable authority requirements. All internal change control procedures incl. e.g. adequate risk assessment / FMEA are to be followed strictly Support product transfer projects between plants from a process stand-point as assigned Support & Manage process or technology transfer projects between plants from a process stand-point as assigned Support new and experimental development activities Support projects and initiatives stemming from the Global Process Engineering team Support/lead Operations Excellence lean and continuous improvement activities Review procedures to ensure they reflect the most effective means and contain the most current and correct information Maintain Process engineering records and documents as required Gather and evaluate In-process control data (CPP graphs, rheological data, etc.) in order to support process improvements and ensure the process Quality Initiate, support, execute CAPA and other quality initiatives Ensure compliance with cGMPs, FDA and other regulations as necessary Prepare reports as may be required on a routine basis or on demand within established deadlines. Safeguard confidential information Maintain effective team member relations Communicate on a regular basis (or as appropriate) with external suppliers of materials and equipment and provide regular feedback on any issues to the management team Attend, schedule, and facilitate internal meetings to help establish priorities and assign tasks. Coordinate the development of documentation in the Production and Technical areas in line with ISO9001 and ISO 13485 requirements and review the systems with the Group Leaders and the Quality department on a regular basis to ensure conformance to same. Conforms with and abides by all regulations, policies, work procedures, instruction and all safety rules Perform other duties as assigned based on business needs The job descriptions reflect the general details considered necessary to describe the principal functions of the job identified and shall not necessarily be construed as a detailed description of all of the work requirements that may be inherent in the job.Basic Qualifications:
Bachelor’s Degree 5+ years of relevent working experiencePreferred Knowledge, Skills and Abilities:
Has general knowledge of business theory and practice; understands the organization’s business plan and how business performance is monitored Prior training in Quality Assurance/Quality Improvement a plus Able to identify and initiate improvement projects from data Comfortable working and communicating with customers Proficient in using computer programs such as: Windows, Word, Excel, Power Point, Visio and Mini-Tab Proficient with Manufacturing Execution Systems, Equipment Interfaces, and HMI Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description Support and contribute in Lean Sigma programs and activities as required Able to comply with the company’s safety policy at all times Equivalent experience in Engineering or ScienceTravel Requirements:
Minimal#LI-KR1
