The engineer is responsible for the conceptual and detailed development of project scopes and processes in a cGMP sterile injectable facility. This includes aspects of project management such as obtaining funding for capital engineering improvements to the plant and production equipment, coordinating design efforts while utilizing reliability engineering concepts as the foundation of design, managing document approvals, and coordinating the procurement, construction, installation, start-up, and commissioning of up to twenty projects simultaneously. The engineer also provides technical support to production, QA, and validation.
Responsible for project management of assigned projects.
Prepare project scopes, processes, and specifications that:
Obtain necessary project funding by preparing RFQ's and CPA’s as required.
Projects under $1,000,000: Manage projects with oversight of Senior Engineers & Engineering Management.
Projects over $1,000,000: Assist Senior Engineers & Engineering Management.
Provide general engineering assistance to senior engineers & engineering management on a timely basis. This includes:
B.S Engineering. Minimum two years of engineering experience in the pharmaceutical/biotech industry. Knowledge of contracting/vendor selection and applicable codes. Familiarity with the latest in pharmaceutical manufacturing equipment and facilities. Working knowledge of ISPE Baseline Engineering Guidelines. Proficiency with Microsoft Office and familiarity with AutoCAD. Professional Engineering license is a plus.
The applicant must have a working knowledge of cGMPs as they relate to sterile pharmaceutical manufacturing and a demonstrated knowledge of pharmaceutical facilities and production equipment, inclusive of their design, installation, and operation. The individual must also demonstrate the ability to use project management techniques and tools in the management of multiple engineering projects.