Sign in

Project Engineer

Sterile Pharmaceuticals Manufacturing
Milwaukee, Wisconsin, United States
September 16, 2017

Project Engineer - $90-110K – Sterile Pharmaceuticals Mfg - Will have responsibility for multiple capital related projects, validation and is a “hands-on", on-the-floor, Project Leader, with a record of designing, and executing projects on time and within budget. The Project Engineer works closely with cross-functional departments to understand the scope, user requirements and needs of the project and develops the project implementation plan. The Project Engineer also reviews and designs for quality compliance, safety, and adherence to company standards, developing communications and risk management plans when needed.

KEY RESPONSIBILITIES: Develops project objectives working with user requirements and business plans; Determines project specifications and technology and completes preliminary technical studies; determines project phases and prepares cost estimates; Participates in internal discussions with internal customers to determine timing for project execution and sequencing of various project milestones; Establishes equipment specifications with internal customers; Works with leaders to schedule and execute validation activities, identifies/resolves validation issues and designs validation test plans. Authors and follows up on closure documentation for IQ, OQ and PQ; Creates and reviews SOPs and related manufacturing process documentation. Performs duties related to Corrective and Preventative Action (CAPA) plans, deviations and Change Control (CC); Provides validation, facilities and utilities support for new or modified equipment used to manufacture new active pharmaceutical ingredients. Request bids from contractors and suppliers by providing; working with procurement group, recommends best provider; Formal CAPEX document preparation and submission; Controls project plan and maintains project schedule by close monitoring of project progress; coordinating activities on critical path; Controls project costs by approving expenditures; administers contracts and monthly expenditures against planned cash flow; Prepares project status reports; Responsible for commissioning and coordinating equipment/areas for validation; Maintains company reputation by complying with applicable federal and state regulations.

Bachelor’s degree in Engineering or related discipline and a minimum of 5 years’ demonstrated construction/project engineering experience. Experience working in pharmaceutical, food or chemical manufacturing environment preferred. Require strong project management skills (i.e. budget tracking, schedule development and adherence project reporting, etc.). Must have GMP experience, understanding of OSHA requirements and experience working in a regulated industry. Experienced in Microsoft Excel and MS Project also needed.