Manufacturing Engineer II

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.

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 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.

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General Responsibilities

• 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.

Qualifications

• 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 requirements preferred

• 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 Wonderware preferred

• MBA and/or PMP certification preferred

• Experience in Solid Dosage Forms preferred

Knowledge, Skills, and Abilities:

• 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

International Vitamin Corporation (IVC) Is an Equal Opportunity Employer. Our organization remains steadfast in our commitment to fostering an inclusive and non-discriminatory work environment that welcomes individuals from all backgrounds. We firmly maintain the belief that every individual ought to be treated with respect and dignity, regardless of their race, color, religion, sex, sexual orientation, gender identity or expression, age, national origin, disability, veteran status, marital status, genetic information, or any other protected characteristic, as defined by the law. We pledge that all eligible job applicants shall receive an impartial and unbiased evaluation during the recruitment process, without any form of discrimination based on any of the protected class. Our dedication to promoting diversity and inclusivity remains unwavering, and we take immense pride in cultivating a workplace culture that values and celebrates differences. Our efforts towards creating an environment that is free from prejudice and discrimination are an integral part of our organizational philosophy, and we stand committed to upholding these principles.