Production Process Engineer
Asheville, North Carolina, United States ・ フルタイム
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- 2時間前
- 作業モード
- 在任中
- 教育
- Bachelor's degree in Mechanical Engineering, Chemical Engineering, Industrial Engineering, Manufacturing Engineering, or related engineering discipline
- 資格
- Professionals with relevant production/process engineering experience in regulated pharmaceutical, biotech, or medical device manufacturing environments may apply.
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仕事内容
Role Overview
This opening is for an experienced Production Process Engineer to support manufacturing operations in Asheville, NC. The role is intended for long-term engagement and focuses on improving production efficiency, strengthening product quality, and supporting regulated pharmaceutical or medical device manufacturing activities.
What You Will Do
- Refine manufacturing and production workflows to raise efficiency, output, and overall quality.
- Track process performance and spot areas where operations can be improved.
- Review production data, study trends, and put corrective and preventive actions into practice.
- Work within GMP, FDA, ISO, and internal quality system requirements.
- Partner with Production, Manufacturing, Engineering, Quality Assurance, and Validation teams to keep operations running smoothly.
- Investigate production problems, perform root cause analysis, and drive lasting fixes.
- Create and revise SOPs, work instructions, process records, and manufacturing procedures.
- Support validation efforts, equipment qualification, and technology transfer tasks.
- Contribute to Lean Manufacturing, Six Sigma, and continuous improvement programs aimed at reducing waste and improving performance.
- Help with deviation reviews, CAPA actions, change control, and preparation for regulatory audits.
Required Background
- A bachelor’s degree in Mechanical, Chemical, Industrial, Manufacturing Engineering, or a closely related engineering field is needed.
- Prior experience in pharmaceutical, biotechnology, or medical device manufacturing is required.
- Strong understanding of process optimization, manufacturing systems, and improvement methods is expected.
- Working knowledge of GMP, FDA regulations, ISO standards, and other regulated manufacturing practices is important.
- You should be comfortable analyzing production data, identifying improvement opportunities, and executing corrective measures.
- Experience with process validation, equipment qualification, and manufacturing documentation is required.
- Strong analytical thinking, troubleshooting ability, and sound decision-making are essential.
- Good communication skills, technical writing ability, and cross-functional teamwork are necessary.
- Experience with Lean Manufacturing, Six Sigma, or similar improvement methods is preferred.
- Exposure to MES, ERP systems, statistical process control, and manufacturing KPI tracking is an added advantage.
Additional Details
This is a full-time onsite position in Asheville, NC. The role is being handled by Stark Pharma Solutions Inc on behalf of a client. The engagement is described as long term. Interested candidates were asked to share an updated resume, along with the best number and time to connect. A LinkedIn company page was mentioned for updates, but no external application link is included here.
Application Note
Candidates who have relevant experience and are open to new opportunities are invited to respond with an updated resume and contact availability.