Project Engineer - 1099/W2
6 days ago
Lincoln
Job DescriptionSalary: • Do you want to get out of the corporate grind of meetings?, • Do you excel at leading capital projects that require you to be a great planner, negotiator, and change leader?, • Are you up to the challenge of leading the transformation of a facility?, • Do you thrive in environments where change isnt easy and requires finesse? This is an opportunity to lead equipment, facility, and utility capital projects at a large biomanufacturing site in the Midwest. Be part of an exciting start-up that supports the worlds 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 CONSIDERED Essential Duties: • Support Capital projects across the project lifecycle (Concept to Closeout), • Develop comprehensive project documentation, including scope, schedule, WBS, and budget • Create and develop documentation across the project lifecycle as needed, to include 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 • Utilize latest CPMP principles to support project success, • Coordinate with internal teams, external stakeholders, and vendors to ensure project objectives are met, • Prepare technical documentation such as drawings, specifications, and reports, • Identify and support permitting requirements, as needed, • Monitor project progress, identify and escalate potential risks, and recommend solutions to mitigate issues • Support procurement activities, including sourcing materials and equipment, to include negotiating with suppliers/vendors, • Identify, procure, and manage vendors and subcontractors, • Perform and support feasibility studies for equipment replacements, utility systems, and facility modifications, • Ensure compliance with any of the following as relevant, • 21 CFR, • GxP, • OSHA, • APHIS, • USP, • EHS, • Client company policies, • Maintain clear communication with vendors, subcontractors and contractors, and clients and stakeholders, • Prepare regular status updates and progress reports for project stakeholders, • Assist in commissioning and qualification phases to verify system performance and compliance, • Develop and improve User Requirement Specifications (URS), working directly with operations and end users to translate process needs into well-defined project requirements, • Develop deep understanding of site manufacturing processes including upstream biologics production, formulation, lyophilization, filling, and packaging and apply that knowledge to drive better front-end project definition Requirements: • APPLICANTS MUST have prior direct experience in a biotech, pharmaceutical, or animal health manufacturing environment to be considered, • Bachelors degree in an engineering field (Mechanical, Chemical, Biomedical preferred), • At least 10 years in a project engineering or project management role in Design/Build Capital projects within an FDA regulated production facility, with primary experience in biologics, pharmaceutical, or animal health manufacturing. The following process areas are a plus but not required:, • Upstream Biologics Production (bioreactors, stainless steel tanks, single-use systems), • Vaccine or Biologics Manufacturing (monoclonal antibodies, vaccines, bacterins), • Lyophilization, • Aseptic Filling, • Formulation, • Weigh and Dispense, • Wet or Dry Granulation, • Blending, • Compression, • Film Coating, • Packaging and Labeling, • Must have direct experience leading Capital projects across equipment, utilities, and facilities in a regulated manufacturing environment (e.g., HVAC/AHU systems, WFI/purified water systems, clean steam, compressed gases, electrical distribution, roofing, and building infrastructure), • Demonstrated experience authoring or developing User Requirement Specifications (URS) and working collaboratively with operations, engineering, and quality stakeholders to define project requirements, • Strong working knowledge of biologics and pharmaceutical manufacturing processes and end-user needs; ability to translate operational requirements into well-defined capital project scope, • Proven experience and expert knowledge in the use of project management tools and methodologies, • Must have direct experience writing business cases and project proposals to secure funding, including managing the project budget across the lifecycle, • Must have direct experience sourcing and managing vendors and subcontractors, • Must have direct experience sourcing and procuring equipment and components, • Proven ability to influence decision making with executive level stakeholders, • Proven exceptional social and diplomacy skills, • Proven ability to lead and manage a team across a multi-departmental project with direct and indirect management of functional resources, • Excellent communication and organization skills, with an analytical and problem-solving mindset, • Documented success leading capital projects in excess of $5MM, • Proven ability to operate under high-pressure in a timeline constrained environment, • Must be fully on-site at the clients manufacturing facility in the Midwest; remote or hybrid arrangements are not available for this role, • Collaborative, patient, and relationship-driven approach to leading change at a site with deep institutional knowledge; must be able to build trust with operators and engineers before pushing new ways of working, • Comfortable working as both an independent contributor and a collaborative team member alongside existing project engineers; able to elevate the capabilities of those around you, • Open to coaching and feedback; brings outside perspective with humility, appreciating that site-level knowledge is valuable and change must be introduced thoughtfully Pre-EmploymentRequirements: • Pass and maintain pre-employment/contract background check and safety certification, including but not limited to outstanding professional references., • Subjecttomotorvehiclereportreview., • Maintainvaliddriverslicenseandendorsementsasrequiredperposition., • Pass pre-employment/contract physical, medical evaluation, and drug screen due to the safety sensitive nature of this position., • Successfully complete and maintain any required safety certification and testing on an annual basis. Work Environment Expectations • This role is expected to be on-site full time at theclientfacility.