What are the responsibilities and job description for the Process Engineer position at Katalyst Healthcares & Life Sciences?
Roles & Responsibilities
- Write and execute validation protocols and reports (IQ, OQ, PQ).
- Develop and implement manufacturing processes, specifications, operator instructions, process studies, and production readiness activities.
- Conduct investigations, root cause analysis, problem solving, and prepare reports/presentations.
- Update procedures, manufacturing specifications, bills, routes, and travelers for product/process changes in PLM systems.
- Work with equipment manufacturers and distributors to develop user requirements.
- Partner with Operations, OpEx, Planning, Engineering, and Quality teams to align validation strategy, author documents, coordinate execution, and manage approvals.
- Ensure adherence to FDA regulations, regulatory requirements, company policies, and operating procedures.
- Identify opportunities for process improvement and implement best practices.
- Maintain positive and cooperative communication with employees, customers, contractors, and vendors.
- Background in medical device or other regulated industries.
- Experience with machining, metal finishing, laser processing, or production automation.
- Practical exposure to machining, casting, finishing, laser processing, or automation.
- Knowledge of statistical data analysis tools (e.g., Minitab).
- Basic understanding of Geometric Dimensioning and Tolerancing.
- Willingness to support global projects, including travel.
- 2-4 years of experience in manufacturing and/or process engineering.
- Strong technical writing skills with awareness of intended audience.
- Ability to effectively communicate with operators, peers, and management in both written and oral formats.
- Handson experience with validation protocols.
- Experience in medical device and/or regulated manufacturing environment.
Interpersonal Skills:
Persuasive communication and strong interpersonal abilities.
Proficiency with Microsoft Office tools.
Salary : $83,636 - $105,936