Job Description

Top Requirements: Minimum of three (3) years of GxP Computerized System Validation (CSV) experience within aseptic filling operations in a validated GxP environment. Additional Buzzword to use from the above bullet: ValGenesis system (Customer uses this to run tests) This is a Digital platform that helps manage the entire validation lifecycle, ensuring compliance, data integrity, and efficiency Proficiency in the authoring and execution of validation documentation, including but not limited to Functional Validation (FV), Configuration Design (CD), and Design Specification (DS). Experience with the validation of Manufacturing Execution Systems is highly desirable. Proven ability to work on-site in Hillsboro, Oregon, for a minimum of two (2) weeks per month. Must reside and work within +/- 3 hours of the Pacific Standard Time (PST) timezone. Immediate availability is required. Project Scope: The role involves supporting the implementation of a new Manufacturing Execution System (MES) called Rockwell Pharmasuite. The project is behind pace and has a heavy amount of work needed to work through testing backlogs. Our consultants will be responsible for running tests using CSV (Computerized System Validation) within aseptic filling operations in a validated GxP environment High-Level Individual Duties: Will be primarily responsible for product transfer activity that is currently on an aggressive schedule. In total there are around 6-7 recipes that need tested. Most of the new hires will be focused here. There will be backlog testing on the product packaging system and Hypercare production Typical workflow for backlog: Writing test protocols Writing test cases Execution of tests Review of test results with Recipe Authors during execution (Testing) or during creation process. EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178. Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico. Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.

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