
Manufacturing Process Specialist
1 week ago
Job Title: Manufacturing Process Specialist
Key Responsibilities:- Oversee the development, implementation, and validation of new manufacturing processes.
- Collaborate with cross-functional teams to track project status and ensure effective execution.
- Communicate with suppliers to determine product process and equipment specifications.
- Mentor or manage technicians, engineers, or interns.
- Document process development, including procedures, protocols, and reports.
- Develop a comprehensive understanding of product design, manufacture, and assembly techniques.
- Estimate resource requirements, workload assignment, and production times for manufacturing processes.
- Train personnel on new design and process development and test methods.
- Select manufacturing sites based on evaluation of internal capabilities and external partners.
- Participate in budgeting and cost control processes.
- Lead technology transfers to manufacturing and serve as a subject matter expert.
Requirements:
- Bachelor's degree in an engineering discipline is required.
- 4+ years of industrial experience in process development, preferably in regulated FDA/QSR and ISO environments.
- Demonstrated hands-on technical expertise with knowledge of cGMP and GLP guidelines.
- Working knowledge of DOE and statistical analysis methods.
- Strong written, communication, and interpersonal skills to lead cross-functional teams.
- Ability to analyze data, interpret results, and prepare reports.
- Capacity to create and execute project plans.
- Familiarity with tooling, design, and drafting principles.
- Training in Six Sigma or Design for Six Sigma is beneficial.
- Experience in design and technology transfers is valuable.
- Process validation experience (IQ, OQ, PQ) is highly desirable.
- PMO certification is a plus.
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