Project Manager

Intellectt Inc; Lincoln (NE); On-site; USD 96,000 - 117,000; Full time

Benefits offered by this job

Health Insurance

401(k) plan

Paid Time Off

Job summary

Intellectt Inc in Lincoln, Nebraska seeks a Capital Projects professional to support lifecycle activities from concept through closeout. You will help define scope, schedule, and budgets, and craft comprehensive documentation including URS, CPAs, and master project plans.

The role requires coordinating with internal teams and external vendors to meet objectives, monitor progress, and ensure compliance with 21 CFR, GxP, OSHA, USP, and EHS.

Responsibilities

• 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 (e.g., CPAs, URS, FS/DS, Master Schedules).
• Coordinate with internal teams, external stakeholders, and vendors to meet project objectives.
• Prepare technical documentation such as drawings, specifications, and reports; identify permitting requirements.
• Monitor progress, identify risks, and mitigate issues.
• Support procurement activities, including sourcing materials/equipment and vendor management.
• Perform feasibility studies for equipment replacements and facility modifications.
• Ensure compliance with 21 CFR, GxP, OSHA, APHIS, USP, EHS as relevant.
• Maintain clear communication with vendors, contractors, clients, and stakeholders.
• Prepare regular status updates and progress reports for stakeholders.
• Assist in commissioning and qualification phases to verify system performance and compliance.
• Develop User Requirement Specifications (URS) with operations and end users.
• Gain deep understanding of site manufacturing processes to improve front-end project definition.

Job description

• 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 and 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 escape 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
• 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

Pay Scale: $70-$85/hr.

• Health Insurance: Medical, dental, and vision options; employees pay the full premium cost.
• Retirement: 401(k) plan available with no employer match or contributions.
• Paid Time Off: No PTO except as required by applicable state and local laws.