Qureos Mentor

GMP Pros

<ul><li>Do you want to get out of the corporate grind of meetings?</li><li>Do you excel at leading large capital projects that require you to be a great planner, negotiator, and change leader?</li><li>Are you up to the challenge of leading the transformation of a facility? </li></ul>This is an opportunity to lead projects for a massive biotech facilities modernization program in the Midwest.Be part of an exciting start-up that supports the world&rsquo;s leading pharmaceutical, biotech, food, and animal health companies. Get the best of both worlds. Gain experience at a company that leads projects for global pharmaceutical companies while enjoying the flexibility, energy, and personal attention that can only be found working in a small, close-knit company.APPLICANTS MUST HAVE PRIOR EXPERIENCE IN BIOTECH, PHARMACEUTICAL, OR ANIMAL HEALTH INDUSTRIES TO BE CONSIDEREDEssential Duties: <ul><li>Support Capital projects across the project lifecycle (Concept to Closeout)</li><li>Develop</li></ul>comprehensive project documentation, including scope, schedule, WBS, and budget<ul><li>Create and develop documentation across the project lifecycle as needed, to include</li></ul>Capital Project Appropriation requests (CPAs), RFPs, Capital Plan, Capital and Expense budget requests, URS, FS/DS, Project plans, Master Project Schedules, WBS, Business Case, SAT/FAT protocols, IOPQ Protocols<ul><li>Utilize latest CPMP principles to support project success</li><li>Coordinate with internal teams, external stakeholders, and vendors to ensure project objectives are met</li><li>Prepare technical documentation such as drawings, specifications, and reports</li><li>Identify and support permitting requirements, as needed</li><li>Monitor project progress, identify</li></ul>and escalate potential risks, and recommend solutions to mitigate issues<ul><li>Support procurement activities, including sourcing materials and equipment, to include negotiating with suppliers/vendors</li><li>Identify, procure, and manage vendors and subcontractors</li><li>Perform and support feasibility studies for new packaging lines</li><li>Ensure compliance with any of the following as relevant: 21 CFR, GxP, OSHA, APHIS, USP, EHS, Client company policies </li><li>Maintain clear communication with vendors, subcontractors and contractors, and clients and stakeholders</li><li>Prepare regular status updates and progress reports for project stakeholders</li><li>Assist in commissioning and qualification phases to verify system performance and compliance</li></ul>Requirements: <ul><li>Must have experience with Capital projects in Utilities/Facilities (roofing, AHUs, electrical systems, etc.).</li><li>Bachelor&rsquo;s degree in an engineering field (Mechanical, Chemical, Biomedical preferred)</li><li>At least&#8239;10 years in a project engineering or project management role in Design/Build</li></ul>Capital projects within an FDA regulated production facility, including experience in one or multiple of the following: Weigh and Dispense, Wet or Dry Granulation, Blending, Compression, Film Coating, Lyophilization, Aseptic Filling, Packaging<ul><li>Proven experience and expert knowledge in the use of project management tools and methodologies</li><li>Must have direct experience writing business cases and project proposals to secure funding, including managing the project budget across the lifecycle</li><li>Must have direct experience sourcing and managing vendors and subcontractors</li><li>Must have direct experience sourcing and procuring equipment and components</li><li>Proven ability to influence decision making with executive level stakeholders</li><li>Proven exceptional social and diplomacy skills</li><li>Proven ability to lead and manage a team across a multi-departmental project</li></ul>with direct and indirect management of functional resources<ul><li>Excellent communication and organization skills, with an analytical and problem-solving mindset</li><li>Documented success leading capital projects in excess of $5MM</li><li>Proven ability to operate under high-pressure in a timeline constrained environment</li></ul>Job Types: Full-time, ContractPay: $65.00 - $85.00 per hourBenefits:<ul><li>401(k)</li><li>Dental insurance</li><li>Flexible spending account</li><li>Health insurance</li><li>Health savings account</li><li>Life insurance</li><li>Paid time off</li><li>Vision insurance</li></ul>Work Location: In person

Project Engineer - W2/1099

Join GMP Pros and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

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Project Engineer - W2/1099