Project Engineer (Pharmaceutical)

HKA Enterprises - Kalamazoo, MI (30+ days ago)4.1


JOB # 164341

Job Description:

The Project Engineer manages high-impact, highly-critical capital projects supporting update and expansion of aseptic filling and freeze-drying operations at large US drug product manufacturing facility.

Manages multiple projects from $1-million to $100-million.

Serve as subject matter expert (SME) for one or more of the following critical aseptic processing areas: formulation and prep, vial handling, vial washing and dehydrogenation, filling, stoppering and capping, traying, lyophilization.

Ensure our aseptic drug processing capital investments use the best technology, have the best outcomes for our business, and align with contemporary standards.

Lead critical aseptic drug product capital investment scoping initiatives.

Develop conceptual designs, preliminary budgets and schedules for assigned projects.

Assist project sponsors with the preparation of Capital Project Appropriation requests (CPAs). CPAs to include project descriptions, justifications, cost estimates, budgets, schedules, analyses of alternatives and other required information.

Develop RFP documents for design services, construction services and major equipment items as appropriate.

Assure appropriate training of impacted maintenance and operating personnel and obtain/distribute testing, certification, validation, "as-built", spare parts, operating or maintenance manual documentation and drawings.

Qualifications:

High school diploma or GED

Bachelor of Science Degree in engineering is required.

Minimum 5 years of engineering and/or project management experience in the pharmaceutical industry is required.

Experience with Pharmaceutical/FDA regulated processes, with a working knowledge of cGMP facility/equipment requirements in aseptic filling/packaging environments.

Ability to communicate well with site operations personnel, skilled trades, site engineering and Architectural & Engineering firms.

Solid understanding of engineering/design packages.

Demonstrates the ability to prepare and administer estimates, budgets, schedules, and the ability to manage multiple priorities.

Job Types: Full-time, Contract

Experience:

  • engineering and/or project management: 1 year
  • pharmaceutical industry: 1 year

Education:

  • Bachelor's