Manufacturing Engineer II

Job Description

The Manufacturing Engineer II provides engineering expertise in the execution of capital projects. On these projects, you will develop and ensure compliance with capital budgets; develop RFPs and equipment specifications; and perform equipment design review, FAT’s, commissioning, and start-up applicable to GMP processing equipment. You will interface with external Architecture & Engineering, construction, and equipment vendors as well as internal site project teams in the execution of strategic projects. You will be responsible for the development of new innovative solutions, identification cost savings opportunities; and provide support to the maintenance teams to troubleshooting equipment problems.

Responsibilities:

• Lead the design, integration, installation, and start-up of capital projects, including estimation, justification, budget, schedule, acquisition, troubleshooting, and documentation.
• Develop User Requirements Specifications, equipment design specifications.
• Lead communications with vendors (OEM’s) and contractors to implement “cutting edge” process and automation solutions.
• Perform Vendor bid analyses and Review/Approve Vendor Documentation.
• Lead Factory Acceptance Tests (FATs), Commissioning and Start-up Activities for projects.
• Assist in the validation / qualification of new systems and equipment.
• Ensure that all specifications, drawings, and ancillary documents are up to date and accurately filed in master data systems.
• Work with production, maintenance, and quality to ensure that PM’s, spare parts, SOPs and other cGMP related documentation are up to date with the latest project installations.
• Serve as a company subject matter expert (SME), maintaining the latest knowledge of bulk formulation equipment technologies, packaging equipment and concepts to support business growth.
• Provide engineering solutions for continuous improvement objectives using industry standard tools and procedures (Change Control, ROI, etc).
• Identify and specify required tooling to meet production requirements.
• Research and evaluate new company suppliers, processes and equipment
• Provide support to maintenance by troubleshooting issues as they arise.
• Limited travel (less than 10%)

Requirements:

• Bachelor’s degree in Engineering
• 8+ years’ Project Engineering experience in the pharmaceutical, biotechnology nutraceutical, or medical device industries
• cGMP and FDA experience
• Strong technical depth of manufacturing equipment, utility and building systems.
• Experience in managing multiple engineering projects and deliverables including budgets and timelines as well as working well in cross-functional teams (internal and external)
• Experience in technical writing including engineering procedures and reports as well as development and implementation of procedures
• Experience with the specification, design, fabrication, and commissioning of equipment and facilities
• Knowledge of Oracle and SCADA systems preferred
• Familiarity with Ignition and Wonderware preferred
• MBA and/or PMP certification preferred
• Experience in Solid Dosage Forms preferred

Other Requirements:

• Self-motivated with excellent leadership, problem solving, communication, and organizational skills
• Comfortable driving day-to-day activities to meet overall project objectives
• Able to Identify and direct all resources (internal / external) required to execute successful projects
• Collaborate and facilitate communication across engineering managers, operations manager, quality managers and other partners to meet cost, schedule, and quality goals
• Create and maintain positive relationships with many internal and external parties
• Lead cross-functional communication between project teams and external vendors
• Provide timely issue resolution and critical path management
• Understand technical issues and drive them to closure by bringing together key partners for decision-making
• Ability to filter and distill relevant information for the right audience
• Self-motivated and dedicated with demonstrated creative and critical thinking capabilities
• Ability to work in a dynamic environment and remain flexible and calm in the face of ambiguity
• Ability to act in an ethical and open manner and consider the impact of decisions