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.
Meet the objectives of the process owner and are compliant.
Are mechanically and financially feasible.
Meet all code and safety requirements.
Are completed within time frame assigned by management.
Obtain necessary project funding by preparing RFQ's and CPA’s as required.
Responsible for project management of assigned projects.
Prepare project scopes, processes, and specifications that:
Provide adequate funding to meet the objectives of the project.
Track and expedite funding to meet the project timelines.
Projects under $1,000,000: Manage projects with oversight of Senior Engineers & Engineering Management.
Coordinate work between engineering or engineering firm, client, vendors, and contractor.
Ensure that all compliance, code, safety, security, and permit requirements are met.
Manage project costs, including field changes, within budget.
Meet all scope requirements.
Meet project timelines.
Projects over $1,000,000: Assist Senior Engineers & Engineering Management.
Submit all pertinent data to Hikma Engineering Services.
Provide liaison support between client, plant services, and Hikma Engineering to ensure full compliance to GMP requirements including design, installation, startup, commissioning, and validation.
Provide general engineering assistance to senior engineers & engineering management on a timely basis. This includes:
Studies, plans, and cost estimates.
Previous capital installations.
Other departments requesting engineering support.
Establishing and implementing project engineering management and compliance systems Improvements.
The administration of reliability engineering in relation to production systems.
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.