Manufacturing Engineer II

Overview Position Overview

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.

This position will be located in AND, DDR, or WOD locations with direct responsibility for the engineering of manufacturing and/or packaging processes in AND, DDR, or WOD locations.

Specific 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 Test, Commissioning and Start-up Activities for your projects.
• Assisting in the validation / qualification of new systems and equipment.
• Ensure that all specifications, drawings, and ancillarydocumentsare 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 (

• Poses no direct threat to the health or safety of himself/herself, of others, or to property. Defined as a significant risk of substantial harm that cannot be eliminated or reduced to an acceptable level by reasonable accommodation.
• Requires regular attendance to perform essential element as contained herein between the assigned start and end times for work.
• Performs such individual assignments as management may direct.
• Other duties as assigned.

• Bachelor’s degree in Engineering, Packaging Science or Construction Management
• 8+ years’ Project Engineering experience
• Experience working in a regulatory environment
• 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 work 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
• Experience working in the Pharmaceutical, Food Production, Biotechnology, Medical Device, or Food & Beverage industries preferred
• Familiarity with current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirementspreferred
• Strong oral and written communication skills.
• Proficiency with Microsoft Office, Microsoft Excel.
• Reads, writes (spelling, grammar, and punctuation), and speaks English
• Following and understanding verbal and written job instructions
• Knowledge of Oracle and SCADA systems preferred
• Familiarity with Ignition and…