Packaging Systems Project Engineer
ASG Renaissance (Kalamazoo, Michigan)

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Packaging Systems Project Engineer

Location:  Allegan, MI (US)

Job Type: Full Time - Direct - Salaried w/ Benefits

Travel : Minimal

Summary:

The Project Engineer is to provide project engineering support for the identification, evaluation, and resolution of equipment related assignments to support corporate objectives and maintain customer service levels while ensuring compliance with FDA cGMP regulations. This position plays a key role by implementing capital projects involving production equipment, providing technical expertise, and ensuring compliance with company practices, policy, procedure, and US FDA regulations.

The Project Engineer must work closely with operations management, cross-functional teams, and outside contractors to collect and evaluate data to achieve corporate objectives while ensuring compliance with FDA cGMP regulations. The Project Engineer is to evaluate and support new production strategies and product introductions for the manufacture of pharmaceutical products. The Project Engineer will manage and coordinate procurement and installation of equipment through the execution of capital expenditures of up to several million dollars and must generate and organize all relevant data to prepare project scopes, cost estimates, economic justifications, and capital appropriation requests, as required, to obtain management approval. The Project Engineer leads project execution and is accountable for the achievement of project objectives through the completion of specific responsibilities including the following; oversee or perform the preparation of system design documentation including User Requirements Specifications (URS) and Functional and Design Specifications (FDS), implement change control, validation planning, equipment selection, specification development, design documentation, procurement activities, contracted engineering services, and construction management, provide installation oversight of equipment supplied using in-house, vendor, or contracted resources to ensure compliance with designated user requirements and cGMP, provide effective interface with the Maintenance Department, and follow good engineering practice (GEP).

Requirements:

 The employee must have demonstrated an advanced understanding of engineering theoretical fundamentals of equipment operation and demonstrate full use of standard principles, theories, concepts and techniques. Hands-on technical knowledge of equipment and validation requirements along with associated machine control systems is required. Also required is experience with change control in a cGMP/FDA-related environment. Strong analytical skills including the demonstrated ability to manage project budgets and develop sound economic analyses are essential. The ability to work independently toward broad goals and to exercise initiative in identifying projects is necessary. The successful candidate must be proficient in personal computer operation including Microsoft Office products.

The qualified person must possess a bachelor degree in Engineering or a closely allied discipline and a minimum of three years engineering experience preferably in a finished pharmaceutical setting. Preferably, the work experience must be directly related to the production of tablets, liquids, or semi-solid products. Candidates must have pharmaceutical packaging experience.