About the job

We are currently growing our Life Science market in the Midwest! As a Project Engineer you will have a direct impact on our future in Life Sciences. We seek a passionate, high achieving professional who thrives in a fast-paced, collaborative, entrepreneurial environment. A leader, mentor, coach with infectious enthusiasm who lifts others to his/her level and exhibits uncompromising dedication to client welfare. A subject matter expert who can meet client needs and guide them in industry leading best practices for complex projects. Execute and lead all phases of design which includes experience with the entire life cycle of projects from concept development through design, implementation, installation, commissioning, and startup.

Responsibilities:
All aspects of project execution including mechanical design and implementation, development of design packages, OEM/contractor management, equipment procurement, installation, start-up, commissioning and qualification support.

• Interface with clients, work on teams of professionals, and provide subject matter expertise in the execution of engineering projects including utilities, facility, process and packaging equipment.
• Manage a project from start to finish in terms of scheduling, milestones, etc.
• help with developing project scope statements, estimates, proposal, development and execution of commissioning and qualification documentation.
• Maintaining and growing solid vendor relationships is a key responsibility.
• Oversee at least 2 vendors and 5 contractors during project execution.
• Responsible for multiple projects ongoing at one time.
• Financial accountability from less than $50K to $500K projects over multiple years.
• Ensure proper change management processes are implemented where needed.
• Assist with project funding requests and project change order requests.

Qualifications:
Minimum of 1 year experience with increasing responsibility in validation/quality service and project experience with life sciences, biotech or other FDA regulated projects.

• Ideally, at least 3-5yrs industry experience
• This position requires experience with some project management, good documentation practices, cGXP, & FDA validation methods and systems, ability to read engineering documents, set priorities, and work on multiple projects simultaneously.
• Understanding of EPCMV, Quality by Design and risk-and science-based approaches for compliance are desired.
• Experience with system and process risk assessments desired.
• Ability to develop specifications (URS, FRS, DDS) for equipment and systems
• This position requires a self-starter, verbal communication, technical writing, some project management tools and word processing skills.
• Diverse experience in being part of project teams related to the commissioning and qualification of clean utilities, facility systems, process support systems, bioprocess manufacturing systems, packaging equipment, and process and cleaning validation is desirable.
• Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 compliance and latest industry expectations for data integrity.
• Multi-discipline collaboration.
• Displayed decision making in a consulting and service environment.
• Willing and able to travel as necessary for project requirements to include but not be limited to: project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.

Education:
Bachelor of Science – Mechanical or Chemical Engineering preferred

https://www.linkedin.com/jobs/view/3350840704/?refId=Ee%2FMe3qWYhBpz0TSRTlRyw%3D%3D

Josefine Fleetwood, (she/her)

Employer Relations Manager

Oregon State University | College of Engineering

116 Johnson Hall  - Room 112

541-737-7286

Josefine.fleetwood@oregonstate.edu