Project Engineer II

5 hours ago

Englewood, Colorado, United States Leiters Inc Full time
Job Description

Leiters Health is seeking a highly skilled Project Engineer II to join our dynamic team. As a key member of our engineering team, you will be responsible for completing engineering projects by organizing and controlling project elements and supporting manufacturing as a Subject Matter Expert (SME) in assigned areas.

Key Responsibilities:

  • Perform engineering design evaluation and ensure projects are delivered on time, at budget, and within scope.
  • Act as a liaison between all stakeholders to develop project requirements and create documentation from scratch, including but not limited to URS, FRS, SAT, and Commissioning documents.
  • Work closely with equipment designers and developers to deliver equipment that meets equipment URS and provide leadership of all equipment-related commissioning, FAT, SAT, and other startup-related tasks.
  • Prepare and distribute a description and timeline of the project, determine project responsibilities by identifying project phases and elements, and assign personnel.
  • Review industry policies and procedures to ensure data accuracy, security, and regulatory compliance, and provide technical support for the engineering process.
  • Prepare project status reports by collecting, analyzing, and summarizing information and trends, and analyze project requirements and perform standard technical calculations.
  • Develop SME knowledge on managed projects and continue to support Manufacturing and other departments after successful completion.
  • Reviews reports of production, malfunction, and maintenance to determine/address problem(s), lead and successfully execute change controls, and CAPAs, and investigate and write deviations.

Requirements:

  • Excellent organizational and documentation skills, detail-oriented, and advanced computer skills to manage projects, track, and analyze data and costs.
  • Excellent teamwork, collaboration, and negotiation skills, comfort with CAD programs, and proficiency with Microsoft Project.
  • Bachelor's degree in Engineering or similar field required, positive attitude, and ability to successfully execute in a fast-paced changing environment.
  • Effective written and oral communication skills, ability to prioritize tasks, and work with minimal direction.
  • Experience in an FDA-regulated environment is required, and 3+ years of relevant experience is preferred.
  • Automation and robotic process controls exposure is also preferred.

Benefits:

  • 100% employer-paid medical plan, dental & vision insurance options including FSA & HSA, employer-paid life insurance & employee assistance program, short-term & long-term disability insurance, up to 4% 401K matching (100% vested on day one), generous paid time off options – vacation, sick, paid leave, and holidays, $5,250 annual tuition reimbursement after 6 months, $1,000 referral bonus program with no limit, and eligible for annual bonus program.

Timeline:

We will be accepting applications on an ongoing basis until the position is filled.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.

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