Project Engineer 1099W2

• 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.

Required Experience:

IC