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JOB SUMMARY The CSV Validation Engineer II shall support CSV team in maintaining the systems/software in its most current validated state. Shall ensure that all required Software/System Development Lifecycle Documents are available. Shall be able to generate and execute validation documents including risk assessments, discrepancy management and reports; assist cross-functional team in identifying the required validation deliverables for new systems/software/equipment or changes to existing validated systems/software/equipment. Collaborate with departments inside the organization to maintain and improve computer system validation processes to ensure robust, efficient, and compliant processes. Have a good understanding and application of regulatory requirements – GxP, Annex 11, ICH Q7A, ASTM E2500 and GAMP JOB DUTIES Assist cross-functional teams in completing system/equipment impact assessments, electronic record and electronic signature assessments. Generate and execute validation (IQ, OQ, and PQ) documentation for computer/computerized systems from supporting GxP manufacturing and QC operations and ensure compliance to site procedures and regulatory requirements. Review completed system/software/equipment assessments, user requirements, and specification documents. Support all CSV-required activities under a Change Control and Validation Maintenance of computerized systems. Author and review validation documents (IQ/OQ/PQ) supporting GxP computerized systems, and relevant infrastructure, including those related to system procurement, audit, performance, compliance and validation. Ensure appropriate regulatory requirements are addressed in the validation protocols. Execute validation/test protocols, follow good documentation practices, support discrepancy/deviations investigations and corrective action identification Author Reports and Trace Matrices for the computerized systems. Perform gap assessments, ensuring compliance is met and maintained. Support system owners and SMEs in addressing identified gaps. Provide support during specification (URS, FS, DDS or CS) document review. Participate in the discrepancy/deviation review and closure. Assess the impact of system changes thru change management; participate in the planning and implementation of change. Ensuring that Process, Equipment and Automation documentation is compliant and inspection ready. Develop and maintain Validation SOPs, forms, documentation and files. PROFESSIONAL SKILLS Excellent written and oral communication to include accurate and legible documentation skills. Ability to work in a fast-paced environment. Team oriented. Independent work skills and a strong work ethic. Microsoft Office and database management skills.   EXPERIENCE At least 3+ years of relevant computer systems validation systems/software/equipment supporting GMP manufacturing operation and laboratory equipment/instruments. Knowledge of global regulations (e.g., FDA 21 CFR Part 11, EudraLex Volume 4 Annexure 11 etc.) and guidelines (e.g. FDA, MHRA Data integrity guidelines, etc.) around quality systems and computerized system validation in Biotech and/or Pharmaceutical industry a plus. EDUCATION Bachelor’s degree in Engineering, Computer Science in related discipline or equivalent. QUALITIES Excellent written and oral communication to include accurate and legible documentation skills. Strong attention to detail. Understanding of group dynamics and teamwork Ability to execute industry best practices and implement these within the framework of existing GAMP regulations.  

Evara Health Institute offers proven healthcare education programs that prepare graduates for immediate employment: Four 9-month certification programs ($7,500 total cost): Medical Assistant, Behavioral Health Technician, Dental Assistant with Expanded Functions, Limited Scope Radiology, and Pharmacy Technician Experienced faculty and modern training facilities Strong job placement rates and employer satisfaction Commitment to addressing barriers that prevent people from entering healthcare careers    

We are looking for a dedicated individual to join our service team. The Service Technician III position includes the following responsibilities: service, maintenance, troubleshooting, testing and general repairs of customers’ MQPower construction equipment. Employee is able to complete duties and responsibilities with minor or no “how-to” instructions or supervision.   Essential Duties and Responsibilities:   Equipment Troubleshooting and Repair Accurately troubleshoot and diagnose standard problems with construction equipment. Perform standard repairs on construction equipment and related supporting accessories. Replace supporting accessories when required. Have a complete understanding of schematics and wiring diagrams.   Inventory Management Track and manage employee-specific inventory during inspection and repair processes. Request equipment and supplies to maintain inventory and ensure availability for necessary jobs.   Mechanical, Electrical, and Hydraulic Component Installation Remove, disassemble, assemble, and install components and parts, including mechanical, electrical, and hydraulic components. Conduct functional and continuity tests of electrical assemblies, components, wire harness, and plugs using electrical testing instruments.   Inspection and Repair of Supporting Systems Inspect and repair all supporting systems, including fuel, cooling, and electrical systems. Perform DOT inspection and repair of all trailers manufactured by Multiquip Inc., with the option for DOT certification testing.   Equipment Testing Properly set up and test equipment using proper testing procedures while ensuring safe operation practices.   Collaboration and Communication Collaborate with other service technicians to ensure safe and customer-satisfactory work. Communicate technical matters clearly, both in written and verbal forms.   Wiring and Electrical Work Cut, route, comb, twist, tie-wrap, and attach wires to terminal points, following layout specifications. Use soldering guns and hand tools to connect wiring to accessories such as relays, circuit breakers, plugs, switches, and solenoids.   Administrative Tasks Prepare and complete service reports in a precise and timely manner. Operate and utilize standard computer programs such as Microsoft Office tools, Adobe Acrobat, web-based service tools, and reporting tools.   Safety and Quality Standards Perform all work in accordance with Multiquip’s established quality standards. Follow all safety procedures and maintain a clean and safe working environment.   Other Responsibilities Must be able to communicate technical matters clearly, both written and verbally. Perform other duties as assigned by the employees’ manager/supervisor. Qualifications Education and/or Work Experience Requirements: High school diploma or (GED) equivalent; Minimum of 5 years of experience on current (2018 and newer) small to medium construction equipment. General engine mechanical/Electrical troubleshooting experience required.   Skills and Abilities: We are looking for a dedicated individual who is a team player with a positive attitude. Is mechanically inclined and able to complete assigned tasks with minimal or no supervision. Has great overall understanding of complex and/or logical functions. Has the ability to travel to job sites for repairs as needed. Has strong problem-solving skills and is detailed oriented with a high level of accuracy. Is able to read and interpret documents such as equipment and environment safety rules, operating and maintenance instructions, electrical & hydraulic schematics as well as written procedures to include troubleshooting flow charts and equipment service manuals.   Licenses, Certifications and Registrations: Valid driver’s license and good driving record.   Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.   While performing the duties of this job, the employee is regularly required to stand. The employee frequently is required to use hands to finger, handle, or feel and talk or hear, kneel, crouch or crawl. The employee will occasionally lift and/ or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus. Compensation and Benefits Base pay range of $28.00-$35.00/hr  Discretionary Bonuses  11 paid Holidays  Generous Paid Time Off - Accrues at a rate of 4 weeks per year to start Paid volunteer Time Off Paid Parental Leave Excellent Benefits Package for Full Time Employee that starts the 1st of the month after 30 days of hire date Retirement Planning - 401(k) Tuition Reiumbursement up to $5,250 a year Employee Referral Program Employee Assistance Program    

The Bath Authority is seeking dynamic Sales Representatives to join our team in Charlotte, NC! In this role, you will meet with homeowners, present bath and shower remodeling solutions, and guide them through a proven sales process. Unlike many home improvement companies, we provide quality, pre-set leads : no cold calling required. To support your success, we also offer a base salary for your first six months of employment as you ramp up and build your sales pipeline. What We Offer: Paid training and ongoing career development Competitive compensation with base + commission and unlimited earning potential Quality leads are provided daily Six-month guaranteed salary to set you up for success Full benefits package including health, dental, vision, and 401(k) Opportunity to grow with one of the fastest-growing home improvement companies in the country What We’re Looking For: Strong communication and interpersonal skills Self-motivated and results-driven Ability to build rapport and deliver excellent customer experiences Previous sales experience preferred, but not required, we provide training Join The Bath Authority and take the first step toward a rewarding sales career where you’ll help homeowners transform their bathrooms and their lives.