Validation Engineer - Maryland, Gaithersburg

The announced job offer is made public by the firm: Ciber Global and it was included in jobs list the date of: 2022-10-22 in the website greenenergyjobsonline.com.

It is announced that they have a job offer at the category of Engineering and the jobs location is in the state of Maryland at the city Gaithersburg, in the country US - at this current ZipCode: 20878

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HTC Global Services wants you. Come build new things with us and advance your career. At HTC Global you'll collaborate with experts. You'll join successful teams contributing to our clients' success. You'll work side by side with our clients and have long-term opportunities to advance your career with the latest emerging technologies. At HTC Global Services our consultants have access to a comprehensive benefits package. Benefits can include Paid-Time-Off, Paid Holidays, 401K matching, Life and Accidental Death Insurance, Short & Long Term Disability Insurance, and a variety of other perks. Job Description: Validation Engineer will be responsible for developing and implementing equipment (facilities, formulation/fill, packaging, and Quality Control), cleaning, sterilization, computer/automation, shipping, and method validation strategies by incorporating good engineering practices, risk-based validation principles and the regulatory requirements. The Validation Engineer will collaborate with internal and external customers by providing oversight and technical guidance throughout the system lifecycle. The Validation Engineer will continually ensure systems and facilities comply with regulatory and Quality process requirements. Major Responsibilities Participates in system design and commissioning project phases. Provides oversight and technical guidance for Facilities, Formulation/Fill, and Packaging engineers during Installation and Operational Qualification. Generates Validation Project Plan for complex projects and systems Supports Risk Assessments documentation including but not limited to, System Impact Assessments, Components Criticality Assessments, Data Integrity Assessments and Automation Risk Assessments Authors Validation Protocols and Reports for cleaning, sterilization, computer/automation, shipping and method processes. Authors Validation Protocols and Reports for Controlled Temperature Units. Supports Periodic Assessments on required frequency intervals Performs Revalidations on required frequency interval Resolves technical issues encountered during study execution Schedules resources to approve and execute validation documents Participating in SOP development as needed Supports equipment start-up, shakedown, and cycle development Interacts with regulatory agencies during inspections to speak to validation program and questions related to process validation life cycle Implements/maintains governing cGMP procedures Ensures training of employees and contractors to assure up-to-date knowledge of practices and procedures Author and review change control documents Find a purpose Help clients embrace emerging technologies. Create inventive solutions and meet intriguing client challenges. Solve, fix, design and innovate. Be a part of something bigger by helping clients go digital, create engaging customer experiences and transform their business. Move ahead Our success as a company is built on practicing inclusion and embracing diversity. HTC Global Services is committed to providing a work environment free from discrimination and harassment, where all employees are treated with respect and dignity. Together we work to create and maintain an environment where everyone feels valued, included, and respected. At HTC Global Services, our differences are embraced and celebrated. HTC is an Equal Opportunity Employer. We respect and seek to empower each individual and support the diverse cultures, perspectives, skills and experiences within our workforce. HTC is proud to be recognized as a National Minority Supplier and an equal opportunity employer of protected veterans. About HTC Global Services Shaping careers since 1990 - our long tenured employees are a testimony of the work culture. Join our global employee base of 12,000 and help us bring human expertise to tech in order to deliver purposeful solutions that amplify value.