| Urgent requirement for Validation Engineer at Irving, TX (Day1 Onsite) at Irving, Texas, USA |
| Email: [email protected] |
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From: Praveen Kumar, Magicforce [email protected] Reply to: [email protected] Job Title: Validation Engineer Location: Irving, TX (Day1 Onsite) Duration: 1+ Year NEED ONLY LOCAL AT TEXAS RATE $55/HR ON C2C Job Description: Under the direction of the applicable Engineering Technical Leader, manages most aspects of multiple projects or initiatives. Role interfaces directly with other facility and corporate functional groups to ensure that goals and objectives are met within GMP/ISO compliance and product design changes are addressed appropriately. Lead multifunctional, cross departmental projects and initiatives geared towards achieving new process/product introductions (NPI), process improvements, cost reductions, and quality improvement. DUTIES & RESPONSIBILITIES Plans, documents, and executes new process development, designed experiments, validations, qualifications, testing, and design control deliverables in order to launch high-quality, compliant new products into manufacturing while meeting time, cost and margin targets. Monitors and supports new product processes until stabilized, and fully transferred into production. Manages and executes projects and/or programs of moderate to high level complexity ensuring safety, regulatory compliance, company standards, operation requirements and business needs are met. Provides project management guidance and business tools, utilizing a systematic approach to project execution. Prepares management reports and presentations. Effective project planning and structure. Develops creative strategies for the efficient completion of projects. Leads the optimization of process output and throughput, equipment utilization, equipment downtime, waste reduction/yield improvements, budget management, standard cost and capital investment management in an innovative manner. Challenges the status quo on a routine basis and develops new ideas within incoming processes. Coordinates phases of work with other departments including R&D, Operations, Regulatory Affairs, Sourcing, Process Excellence, etc. Technical support to Manufacturing Business Units for complex process issues, where higher level of technical expertise in a given field of knowledge is required. Follows Standard Operating Procedures (SOP), Good Manufacturing Practices (GMPs), Company Policies and Federal, State and Local Government Regulations. Revise and maintain engineering, equipment and process procedures. Coordinates communications and interfaces with end users, machine manufacturers and/or suppliers. Writes, develops and implements validation procedures. Reviews and analyzes data, understanding of statistics and the application of statistical data, able to determine normal and non-normal data along with probable causes of non-normal results EXPERIENCE AND EDUCATION Bachelors degree in engineering discipline. Six to Eight (6-8) years minimum experience in engineering in a medical device environment preferred. REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS. Advanced computer skills and use of software applications. Strong computer background (MS Office, MS Project Management, PowerPoint, Word, Excel, Outlook etc.) Experience in a manufacturing environment developing manufacturing standards. Proficient in project management, creating credibility within team members and expanding capabilities of the group. Experience or knowledge in short and long-term project management. Strong Organizational, interpersonal, oral and written communication skills. Ability to prioritize multiple commitments and technical problem-solving duties. Ability to shift priorities according to changes in department/facility needs and open to different ideas/approaches. PHYSICAL WORKING CONDITIONS / REQUIREMENTS Ability to work in an office environment Ability to engage associates in manufacturing locations LOCATION & TRAVEL REQUIREMENTS Primary location is in Irving, TX Occasional travel, including international (up to 10%) EXTERNAL INTERACTIONS Required occasionally to interact with surgeons and/or key opinion leaders on site or on location. Required to interact with external suppliers to develop new materials, components or finished goods. Keywords: rlang microsoft Texas Urgent requirement for Validation Engineer at Irving, TX (Day1 Onsite) [email protected] |
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| 07:50 PM 05-Mar-25 |