LIMS Project Manager Job Summary : Talent Software Services is in search of a LIMS Project Manager for a contract position that can be worked 100% remotely. The opportunity will be six months with a strong chance for a long-term extension. Position Summary : Under limited supervision, the LIMS Project Manager plans, schedules and ensures timely completion of milestones in LabVantage LIMS milestones supporting digital manufacturing and ensuring the integrity of the current LIMS system and data as built. Works with internal stakeholders to determine project objectives and business requirements. Provides budget analysis, resource allocation and coordination of project activities that may be across functional areas within the organisation. Assigns and monitors the work of technical personnel, ensuring that project steps are delivered on time and within budget. Monitors for any risks or issues that appear during the project and works with the project team to escalate and implement mitigation plans to resolve them. Primary Responsibilities / Accountabilities : Creates, revises and maintains Master data in the LabVantage LIMS system, supporting in process testing and positive / negative result feedback look to go through UNS. Familiar with Industry 4.0 concepts and provides support in maintaining Quality standards throughout. Navigates LabVantage LIMS master data functional issues with management, IT or service provider as necessary. Will support testing functionality and validation efforts for LIMS data automation connections with UNS and Tulip. Builds dashboards and reports supporting batch status and information transparency. Performs other LabVantage LIMS / quality duties as assigned. Using the company's project management tool, reserves and allocates technical resources, and coordinates LabVantage LIMS specific project activities. Assigns, monitors and executes work of technical personnel across all phases of the project, including development, testing, and initial support upon implementation. Ensures that project steps are in alignment with business objectives. Monitors for any risks or issues that appear during the project and works with the project team to implement mitigation plans to resolve them. Provides project status to key stakeholders. Facilitates and documents RACI and change control process. Setup collaboration, Jira and other tools for the project team. Facilitates, documents, and gets sign off for deployment, communication, training and business readiness plans. Tracks that testing plans and preparation is documented and executed. Uses project management best practices and company standards and tools to successfully deliver assigned projects. Qualifications : Bachelor's degree in IT, IS, Engineering, Life Sciences, or equivalent. 5 years of demonstrated experience successfully managing medium to large IT / Quality System projects. 2-4 years of laboratory and infrastructure experience required. LIMS Master Data experience is required. Understanding of data flow requirements in LIMS systems. Foundational experience working with LabVantage LIMS 8.8 and 8.9 versions. Experience managing project scope using a formal change management process Demonstrated experience in creating and managing stakeholder communication plans PMI certification (PMP) desired Formal training or experience working with MS Project, MPP tools, JIRA , SharePoint, MS PowerPoint, and Visio Solid understanding of project and portfolio management, including knowledge of various project methodologies (agile, waterfall) Infrastructure and IT software acumen Preferred : Excellent written / verbal communication and presentation skills to deliver project information to stakeholders at all levels (associates and executives) Exhibits a high level of professionalism in communication, appearance, attention to detail, and accountability Ability to identify project risks early and develop plans to mitigate them A self-starter with excellent time management skills who thrives in a fast-paced environment and has ability to manage and prioritize concurrent work assignments Leadership skills to manage associates and other parties in a matrix environment Excellent interpersonal skills to manage relationships and to deal with conflicts in a professional and objective manner Must be able to learn new tools and processes quickly and effectively Ability to effectively manage vendor, contractor and business partner relationships during the project duration; clear understanding of key accounting concepts (capitalisation vs. expense) Familiarity with LabVantage LIMS, ETQ and JIRA. Understanding of regulatory requirements for 21 CFR Parts 11, 210 / 211, and 820, ISO 17025, GxP principles, including change management, data integrity and laboratory processes. Complete project lifecycle experience in biotechnology, pharmaceutical or process-based industries, preferably at an enterprise software product company in an external customer-facing role. Broad understanding of relevant technologies and implications in the delivery of scientific solutions, such as but not limited to an understanding of IT processes, SDLC methodologies, Quality Management System, Validation, et al. If this job is a match for your background, we would be honoured to receive your application! Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities, including contract, contract to hire, and permanent placement. Let's talk!
Project Manager • Morrisville, NC, US