Sr. Process Engineer

Category: 
Manufacturing & Engineering
Job Location: 
Lake Forest, IL

Are you highly motivated, organized, and want to join a growing company in a fast-paced environment?  Do you enjoy working in a team atmosphere? Our client, a leading provider of high quality Compounding Sterile Preparations (CSP's), is in need of an impact employee. If you would like to be part of a successful team, then you could be what our client is looking for in their Sr Process Engineer. This is an excellent opportunity that offers a competitive compensation package.  If this is for you or someone you know, please forward a current resume to tim@pointonerecruiting.com 

 

Job Description:

Provide technical skills and expertise in various areas that may include automated equipment design and selection, manufacturing processes improvement and support, and packaging design, selection, and improvement. Provide technical skills and abilities to assure projects meet schedule and budget commitments. Success is measured through the generation and implementation of projects that meet the desired outcome, budget, timeline, and processing goals. Significant travel is required during development and implementation of projects at the various compounding centers.

Implementation of new, improved, and/or expanded equipment for new and existing service offerings. Includes responsibility for defining process requirements, budgeting, design & interfacing with vendors of equipment and tooling, and maintaining appropriate documentation for new equipment and processes including qualification, verification, and validation.

Implementation of new or improved packaging solutions for new and existing product offerings. Includes responsibility for defining packaging requirements, design & interfacing with package vendors, calculation of cost savings, conducting testing as necessary, and maintaining appropriate documentation.

Manage multiple medium to large projects concurrently; create implementation plans then prioritize activities and closely manage project milestones of assigned projects; identify options and contingencies to keep numerous active projects on track; focus efforts on appropriate activities after narrowly defining scope of work.

Troubleshoot equipment and processing issues to support compounding operations; determine calibration and maintenance needs of new equipment.

Develop and implement necessary SOPs; train pharmacists, operators, and maintenance personnel on equipment and SOPs; establish processing, packaging, and test specifications for products and equipment. 

Maintain compliance to (and accelerate where possible) project time lines and plans; maintaining project or capital costs to within approved budgets.

Write, review, and execute validation protocols and reports; perform validations of new automation equipment, processes, and other process related equipment.

Provide an engineering-based validation review and input for CAPAs; review technical merits of proposed change control documentation.
 

Requirements:

B.S. in Mechanical Engineering or related Engineering field. 

Minimum of 7-10 years of experience in medical device and/or pharmaceutical manufacturing.  

Demonstrated results in implementing automation and/or packaging solutions on time, within budget, and meeting specified requirements; demonstrated results managing many projects concurrently.

Experience in aseptic processing preferred.

Innovative, decisive, results oriented individual contributor with strong problem-solving skills.

Must possess the ability to work effectively with all levels of organization.  

Must possess excellent interpersonal, communication, and writing skills, ability to analyze technical issues, define/solve problems, establish project plans, statistically evaluate solutions, and draw valid conclusions. 

Very familiar with FDA, GMP, and ISO standards.  

Must be proficient in Microsoft Word, Project, Excel, and Outlook.

 

Apply Now!  Send resumes to tim@pointonerecruiting.com     

Recruiter Name: 
Tim Borop
Recruiter Phone: 
(262) 886-8000 ext. 218

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