Manufacturing Process Engineer
$67K - $90K/yr
We are seeking a Manufacturing Process Engineer to support manufacturing operations by developing, optimizing, and validating production processes to improve efficiency, quality, and productivity.
Ipsen
63 Ipsen Manufacturing Process Engineer Jobs Hiring Near You
Manufacturing Process Engineer
$67K - $90K/yr
We are seeking a Manufacturing Process Engineer to support manufacturing operations by developing, optimizing, and validating production processes to improve efficiency, quality, and productivity.
Manufacturing Process Engineer
Detroit, MI ยท On-site
$72K - $97K/yr
Manufacturing Process Engineer Work Arrangement: This role is categorized as onsite. This means the successful candidate is expected to report to our Detroit/Hamtramck plant location Sponsorship: GM ...
Manufacturing Process Engineer
Detroit, MI ยท On-site
$72K - $97K/yr
Manufacturing Process Engineer Work Arrangement: This role is categorized as onsite. This means the successful candidate is expected to report to our Detroit/Hamtramck plant location Sponsorship: GM ...
Manufacturing Process Engineer
Erie, PA ยท On-site
$100K - $120K/yr
1. Provide technical assistance to plant operations to facilitate the resolution of manufacturing and process engineering issues; assist with the development of plans to meet current and future needs ...
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Manufacturing Process Engineer
Erie, PA ยท On-site
$100K - $120K/yr
1. Provide technical assistance to plant operations to facilitate the resolution of manufacturing and process engineering issues; assist with the development of plans to meet current and future needs ...
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$67K - $90K/yr
Full-time
Re-posted 16 days ago
Job description
Job Description:
We are seeking a Manufacturing Process Engineer to support manufacturing operations by developing, optimizing, and validating production processes to improve efficiency, quality, and productivity. The ideal candidate will work closely with Manufacturing, Quality, Operations, R&D, and Supply Chain teams to drive continuous improvement initiatives, resolve production issues, and ensure compliance with safety and regulatory requirements in a fast-paced manufacturing environment.
Roles & Responsibilities:
We are seeking a Manufacturing Process Engineer to support manufacturing operations by developing, optimizing, and validating production processes to improve efficiency, quality, and productivity. The ideal candidate will work closely with Manufacturing, Quality, Operations, R&D, and Supply Chain teams to drive continuous improvement initiatives, resolve production issues, and ensure compliance with safety and regulatory requirements in a fast-paced manufacturing environment.
Roles & Responsibilities:
- Develop, implement, and optimize manufacturing processes to improve productivity, quality, and cost efficiency.
- Analyze manufacturing workflows and identify opportunities for process improvements using Lean Manufacturing and Six Sigma methodologies.
- Support new product introduction (NPI), process development, and technology transfer activities.
- Design, validate, and document manufacturing processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), where applicable.
- Investigate production issues, perform root cause analysis, and implement corrective and preventive actions (CAPA).
- Create and maintain process documentation, work instructions, Standard Operating Procedures (SOPs), and manufacturing specifications.
- Collaborate with cross-functional teams including Manufacturing, Quality Assurance, R&D, Maintenance, Supply Chain, and Regulatory Affairs.
- Support equipment selection, installation, commissioning, and validation activities.
- Monitor process performance using statistical tools such as Statistical Process Control (SPC) and process capability analysis.
- Lead continuous improvement initiatives focused on cycle time reduction, waste elimination, yield improvement, and cost savings.
- Participate in Failure Mode and Effects Analysis (FMEA), risk assessments, and process validation activities.
- Support manufacturing scale-up, process transfers, and production line improvements.
- Ensure compliance with company quality systems, safety procedures, and applicable regulatory requirements including GMP/cGMP, FDA, and ISO standards.
- Train manufacturing personnel on new processes, equipment, and standardized work procedures.
- Prepare technical reports, engineering documentation, and project status updates.
- Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Chemical Engineering, Biomedical Engineering, or a related engineering discipline.
- 2-5 years of manufacturing or process engineering experience.
- Experience supporting manufacturing operations in regulated or high-volume production environments.
- Knowledge of Lean Manufacturing, Six Sigma, and Continuous Improvement methodologies.
- Experience with process validation, root cause analysis, and problem-solving techniques.
- Strong understanding of manufacturing documentation and engineering change processes.
- Excellent analytical, organizational, and communication skills.
- Proficiency with Microsoft Office Suite.
- Experience in Medical Device, Pharmaceutical, Biotechnology, Automotive, Aerospace, or Electronics manufacturing.
- Knowledge of GMP/cGMP, FDA regulations, ISO 13485, ISO 9001, or AS9100.
- Experience with CAD software (SolidWorks, AutoCAD, Creo, or equivalent).
- Familiarity with ERP and Manufacturing Execution Systems (MES).
- Green Belt or Black Belt certification in Lean Six Sigma.
- Experience with automation, robotics, PLCs, or manufacturing equipment integration.
About Katalyst Healthcares & Life Sciences
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Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.
Industry
Scientific research and development services
Company size
51 - 200 Employees
Headquarters location
South Plainfield, NJ, US