GMP Pros® · 2 months ago
Project Engineer (Facilities) - 1099
Lincoln, Nebraska, United States
Full-time
Onsite
Senior Level, Lead/Staff
$65/hr - $85/hr
10+ years expGMP Pros® is a start-up supporting leading pharmaceutical, biotech, food, and animal health companies. They are seeking a solutions-oriented Project Engineer to support Capital Projects, ensuring project objectives are met and documentation is developed throughout the project lifecycle.
Business DevelopmentBusiness Information SystemsPharmaceutical
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 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 new packaging lines
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
Qualification
Required
APPLICANTS MUST HAVE PRIOR EXPERIENCE IN BIOTECH, PHARMACEUTICAL, OR ANIMAL HEALTH INDUSTRIES TO BE CONSIDERED
Must have experience with Capital projects in Utilities/Facilities (roofing, AHUs, electrical systems, etc.)
Bachelor's 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, including experience in one or multiple of the following: Weigh and Dispense, Wet or Dry Granulation, Blending, Compression, Film Coating, Lyophilization, Aseptic Filling, Packaging
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
Company
GMP Pros®
GMP Pros, Inc.® helps manufacturers in Food, Pharma, Animal Health, and Biologics overcome capacity, efficiency, and quality challenges.
11-50 employees
H1B Sponsorship
GMP Pros® has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
2022 (5)
2021 (2)
2020 (1)
Funding
Current Stage
Early StageLeadership Team
S
Stephanie M. Clark
Co-Founder & Co-Chief Executive Officer, GMP Pros® Projects
Company data provided by crunchbase