Project ManagerEngineer 1099
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Job Location:
Lincoln, NE - USA
Monthly Salary:
$ 65 - 85
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
We are seeking a solutions and process-oriented Project Manager with a heavy background in Project Engineering to support Capital Projects for a key client.
Be part of an exciting start-up that supports the worlds leading pharmaceutical biotech food and animal health companies. Attain 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 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
Requirements:
- Bachelors degree in an engineering field (Mechanical Chemical Biomedical preferred)
- At least10 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
Required Experience:
IC
Key Skills
- Primavera
- Microstation
- Bluebeam
- Construction Estimating
- Construction Experience
- ProCore
- Mechanical Engineering
- Project Engineering
- Project Management
- Autocad
- Project Management Software
- Microsoft Project
About Company
We are a leading FDA regulatory compliance monitoring & consulting agency, ensuring high standards in the development, testing & labeling processes. Contact us today.
