Somerset, NJ QA Engineer (QAE) NJ 08873

Job description

We are seeking an experienced Quality Engineer-CSV to support the administration, validation, maintenance, and continuous improvement of computerized and electronic Quality Systems across laboratory, manufacturing, and Quality operations. • Administer and support PLCs, SCADA systems, Windows-based applications, laboratory instruments, manufacturing systems, and enterprise applications. • Support system administration activities including user/role management, security configuration, audit trails, backup/restore, reporting, and other system configurations. • Provide end-user and operational support for Veeva Vault QMS, QualityDocs, Vault Training, and other quality systems. • Maintain and improve electronic Quality Systems, including workflows, configurations, procedures, and system processes. • Develop and monitor Quality System metrics/KPIs, identify trends, and present results and improvement opportunities to management. • Identify opportunities to simplify, standardize, and improve the efficiency of Quality and computerized system processes. • Perform CSV and data integrity activities including risk assessments, URS, configuration specifications, testing/UAT, RTM, validation reports, periodic reviews, and SOP updates. • Support qualification (Installation, Operational, and Performance Qualification) reviews of laboratory instruments and manufacturing equipment. • Partner with Quality, IT, Engineering, vendors, and business users to troubleshoot issues and implement system enhancements. • Ensure compliance with 21 CFR Part 11, 21 CFR Part 211, EU Annex 11, GAMP 5, Data Integrity. Qualification and Experience Strong knowledge of GAMP 5, Annex 11, CSV, data integrity, and applicable FDA/EU requirements. Experience with Veeva Vault or similar electronic Quality Systems preferred. Strong analytical, troubleshooting, communication, and stakeholder-management skills. Hands on knowledge on Veeva, LIMS, ELN, SAP, and MES systems is preferred 3-8 years of experience in Quality Systems, CSV, systems administration. Experience supporting laboratory, manufacturing, and/or enterprise computerized systems The anticipated salary range for this position in New Jersey is $70,000 .00 to $90,000.00, plus discretionary 7.5% performance bonus (based upon eligibility). The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Lupin is a multi-state employer, and this salary range may not reflect positions that work in other states. Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law. Physical Requirements The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment. Search Firm Representatives Please Read Carefully Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails Competencies Collaboration Customer Centricity Developing Talent Innovation & Creativity Process Excellence Result Orientation Stakeholder Management Strategic Agility Nearest Major Market: New Jersey Apply now » Apply Now Start applying with LinkedIn Please wait... Find similar jobs: Lupin-United States Cookie Consent Manager When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer. Required Cookies These cookies are required to use this website and can't be turned off. Required Cookies Required Cookies Provider Description Enabled SAP as service provider We use the following session cookies, which are all required to enable the website to function: "route" is used for session stickiness "careerSiteCompanyId" is used to send the request to the correct data center "JSESSIONID" is placed on the visitor's device during the session so the server can identify the visitor "Load balancer cookie" (actual cookie name may vary) prevents a visitor from bouncing from one instance to another Cookies from provider SAPasserviceprovider are required and cannot be turned off Advertising Cookies These cookies serve ads that are relevant to your interests. You may freely choose to accept or decline these cookies at any time. Note that certain functionality that these third parties make available may be impacted if you do not accept these cookies. Consent to all Advertising Cookies Advertising Cookies Provider Description Enabled LinkedIn LinkedIn is an employment-oriented social networking service. We use the Apply with LinkedIn feature to allow you to apply for jobs using your LinkedIn profile. Opting out of LinkedIn cookies will disable your ability to use Apply with LinkedIn. Cookie Policy Cookie Table Privacy Policy Terms and Conditions Consent to cookies from provider LinkedIn