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20 days old

Process Engineer

Kelly Services
Fenton, MO 63026
Process Engineer (Fenton, MO)

Leading Pharmaceutical company in Fenton, MO, is currently hiring a Process Engineer. This position is a Direct Hire role.


Privately held company; 75,000 square foot facility located in Fenton, MO that supports Production and Manufacturing areas, in addition to Microbiology, Quality Assurance, Quality Control, and Research & Development departments.


The Process Engineer is new role, pieces Regulatory, Engineering, Quality, Project Management, and Operations roles combined. Role performs sustaining engineering activities on current and future product packaging and packaging processes, with priorities based on quality and compliance, continuity of supply, and cost savings initiatives. When applicable, will also support new product development teams by acting as an extended team member to provide the design, development, and verification testing of new product packaging and assist manufacturing in qualification of new packaging equipment/processes. The right person should be able to lead a process improvement task from start to finish (brainstorm idea, present to department, implement and follow-through).

Related experience within pharmaceutical/medical device manufacturing with an emphasis on packaging systems, equipment design and operation required.


Primary Responsibilities and Essential Functions of the Position:

Develop and manage capital project schedules in order to meet overall program goals, including budget and timeline.

Perform equipment impact studies to meet overall program goals, including budget and timeline.

Lead internal and external design reviews to ensure timely execution of project plans.

Ensure success equipment and systems delivery qualifications, integration, and manufacturing validation.

Provide hands-on mechanical support for serialization, labeling and packaging equipment as needed by production.

Evaluate and upgrade all labeling and packaging equipment, including design changes on the labeling and packaging equipment to improve functionality and automated vision inspections.

Assist Validation in IQ, OQ, and PQ validations for new equipment or improvements or modification of current equipment in support of assigned projects.

Issue new, or revise, current Manufacturing or Engineering procedures, as needed.

Lead projects with increased complexity and scope.

Effectively manage multiple projects with minimal assistance and supervision.

May lead a large- scale program or several small projects with complex features.

Create project plans and organize resources to ensure project milestones are met within expectations of timeline, quality, and budget.

Review and approve product engineering change orders and packaging process changes, including label specifications and packaging related content.

Consult with vendors in the development of packaging for components and materials.

Provide technical support to establish supplier quality standards and support supplier audits, as needed.

Create packaging related Standard Operating Procedures (SOPs) and Work Instructions. Provide training for appropriate personnel performing packaging activities.

Approve new packaging materials and systems, studying and recommending techniques to improve and/or reduce cost of existing products and processes; investigate sources for new packaging materials.


Qualifications:

Experience leading and supporting process equipment and control systems.

Experience overseeing control system design and implementation.

Minimum 3 years of related experience within pharmaceutical/medical device manufacturing with an emphasis on packaging systems equipment design and operation required.

Bachelors degree in business, packaging or relevant engineering degree (e.g. mechanical, chemical, biomedical for engineering role) preferred. (The right person without a degree may also be considered, but will be offered Coordinator, not Engineer, title).


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-05-24 Expires: 2021-06-24

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Process Engineer

Kelly Services
Fenton, MO 63026

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