Location: King Of Prussia, PA
Company: Usdm Life Sciences
technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of Gx P projects globally. As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, Docu Sign, Box, and many more.
From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM's clients. Are you ready to make an impact and drive real digital transformation in life sciences? Founded in Santa Barbara in 1999, USDM has grown to a progressive,
global company with 300+ remote employees and offices throughout the US, Canada, and Germany. Nature and Scope of Job USDM is looking for an experienced Validation Engineer who will play a key role in the qualification of Next-Generation Sequencing (NGS) systems such as Miseq Denovix , Tapestation, Blue Pippin, Excel spreadsheet - Library Prep calcs, Geneious, Snapgene and script qualification.
The ideal candidate will have a strong background in computer system validation processes, with a focus on ensuring the reliability and compliance of NGS systems used in our client's organization. Primary Responsibilities 1. System Qualification: Lead the qualification efforts for NGS systems,
ensuring adherence to regulatory standards and internal quality guidelines.
Develop and execute Validation plan (VP), Chane controls, Specs documents (URS, FRS, CS, DS) validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), RTM, VSR etc. 2. Documentation: Generate and maintain comprehensive validation documentation, including protocols, reports, and SOPs. Collaborate with cross-functional teams to ensure alignment with project timelines and quality standards. 3. Risk Management: Conduct risk backssments related to NGS system qualification and implement mitigation strategies.
Stay informed about industry best practices and regulatory requirements to enhance risk management processes. 4. Collaboration: Work closely with R&D, Manufacturing, and Quality Assurance teams to integrate validation activities into the overall project plan. Provide technical expertise and support to cross-functional teams during the design and implementation phases. 5. Continuous Improvement: Identify opportunities for process improvement and optimization within the validation framework. Implement best practices to enhance efficiency and effectiveness in NGS system qualification. Qualifications Proven experience in the validation of laboratory equipment, with a focus on NGS systems preferred.
Familiarity with regulatory requirements (FDA, ISO, etc. ) related to validation in a Gx P environment. Strong analytical and problem-solving skills with attention to detail. Excellent communication and interpersonal skills to work collaboratively in a cross-functional team. Education & Certifications Bachelor's degree or higher in a relevant scientific or engineering discipline. Working Conditions The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job, and are not meant to be all inclusive.
Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job. Unless reasonable accommodations can be made, while performing this job the staff member shall: Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment. Operate other office productivity machinery, such as a calculator, scanner, or printer.
Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations. Equal Opportunity Statement USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, national origin, disability, or status as a protected veteran. Disclaimer This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position.
It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. PDN-9ac9aadf-c938-4735-b45b-0d9300cc46da
Engineering jobs encompass a variety of roles focused on designing, developing, and maintaining structures, machines, and systems. These roles often require a strong foundation in math and science, as well as specialized knowledge in disciplines such as civil, mechanical, electrical, or software engineering. Key features of these jobs include solving technical problems, innovating solutions, and improving functionality and efficiency. Engineers typically work in collaborative environments, bridging theoretical concepts with practical applications to advance technology and infrastructure.
Engineering jobs encompass a broad range of careers focused on designing, developing, and maintaining structures, systems, and devices. They are characterized by a strong foundation in mathematics, physics, and technology. Engineers often specialize in fields such as civil, mechanical, electrical, or software, striving for innovation and problem-solving. These roles typically require critical thinking, collaboration, and a relentless pursuit of efficiency and functionality. Engineering careers are instrumental in shaping the future, as they constantly push the boundaries of what's possible in construction, manufacturing, communications, and various other sectors.
Engineering jobs encompass a variety of roles focused on designing, developing, and maintaining structures, machines, and systems. These roles often require a strong foundation in math and science, as well as specialized knowledge in disciplines such as civil, mechanical, electrical, or software engineering. Key features of these jobs include solving technical problems, innovating solutions, and improving functionality and efficiency. Engineers typically work in collaborative environments, bridging theoretical concepts with practical applications to advance technology and infrastructure.
missions. Headquartered in Chantilly, VA and with 16 offices around the world, Arcfield employs approximately 1,200 engineers, analysts, IT specialists, and other professionals who put our customers’ missions first, helping them solve their most complex challenges through innovations in modeling, simulation and analysis, digital transformation and C5ISR.
Visit for more details. Responsibilities Are you looking to join a company that’s mission focused and innovation driven? Arcfield provides systems engineering, integration, and digital transformation across space, air, land, sea, and cyber domains. This position is for a Systems Engineering and Technical Assistance (SETA) Requirements
Engineer within Space and Mission Engineering. Your responsibilities are to write Requests for Changes (RFCs) for GEOINT Software systems, interfaces, and specifications.
Join a well-established contract that has a long history of excellence in Systems Engineering and Acquisition. Responsibilities include: Holding Technical Exchange Meetings (TEMs) with developers and engineers to gather requirements, interface, and specification updates Redline changes to existing requirements Initialize and lead RFCs through community review and Engineering Review Board(s) backss impacts from other author’s Requests for Changes (RFCs) Update architecture artifacts (e. g. system views, functional views,
sequence diagrams) Update Interface Control Documents (ICDs) Attend Software acquisition Program Management Reviews (PMRs) and ensure requirements are being met within quality specifications and prior to milestone deadlines Participate in Agile Solution Epic working groups where requirements are translated into capability descriptions that can be planned into Developer increments Qualifications Required : BS 8-10 Years, MS 6-8, Ph D 3-5 Must Possess and be able to maintain a TS/SCI with Poly Experience writing RFCs for GEOINT systems Experience with the acquisition and management of Software development contracts Strong representational, oral, and written communications skills, including the ability to produce clear, logical, and concise products Proven organization and interpersonal skills, and demonstrated ability to interface effectively via written and oral forums with personnel at all levels of government Desired : Knowledge of GEOINT mission management and mission processing systems Knowledge of GEOINT products and data EEO Statement EEO Arcfield proactively fulfills its role as an equal opportunity employer.
We do not discriminate against any employee or applicant for employment because of race, color, interaction, religion, age, interactionual orientation, gender identity and expression, national origin, marital status, physical or mental disability, status as a Disabled Veteran, Recently Separated Veteran, Active-Duty Wartime or Campaign Badge Veteran, Armed Forces Services Medal, or any other characteristic protected by law.
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