Description:
What are the top 3-5 skills, experience or education required for this position:
BS of Engineering, Science, or closely related discipline w/ 2-3 yrs experience in Pharmaceutical or related
Experience with Cleaning Validation, Process Validation and Process Monitoring
Experience with I/O/PQ for equipment qualifications
Acknowledgeable with One-Vault, TrackWise, Microsoft PowerPoint and Statistical Software.
Support and monitoring Production as required to troubleshoot process and cleaning.
Job SUMMARY:
The Process Engineer II is responsible for providing 1st shift engineering production support including:
- Implementing process and technology improvements
- Regular on-the-floor manufacturing support
- Collecting, monitoring, analyzing, troubleshooting, and reporting manufacturing data related to performance in the areas of quality, cost, and speed/service to market
- Investigating non-conformances, CAPAs, process performance drifts and implementing corrective and preventative actions
- Conducting Technical assessments of change orders and Supplier Change Requests
- Responsible for the initiation and follow-through of the change control processes.
job QUALIFICATIONS (MINIMUM REQUIREMENTS):
The requirements described in this section are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Education and Experience
- A Bachelors Degree in Engineering, science or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 2+ years of significant engineering and/or operational experience. Additional post-graduate education may contribute towards the desired years of experience.
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
- Experience with MS Office applications including Word, Excel & Outlook
- Demonstrated understanding and use of statistical methods in experiment design and data analysis
- Able to work independently and proactively in conjunction with all levels of the organization
- Experience with Quality System Regulations (QSR) and working in a medical device regulatory environment, generating manufacturing process documentation, FMEA and Risk Assessments, Design Control, Human Tissue Regulations, and Sterilization Validation Standards
- Six Sigma, Value Stream Mapping, Lean Manufacturing, Design for Manufacturability, DOE
- Biological Products and aseptic processes
- Development of robust manufacturing processes, validation, and process monitoring
- Experience with root cause analysis methods
- Experience with applications including Minitab or other statistical software, Microsoft PowerPoint, Project, and Visio.
Preferred Skills
- Time management skills and follow-through skills with the ability to work on and manage multiple tasks with tight deadlines.
- Strategic thinking and planning.
Enable Skills-Based Hiring No Provide the days of the week and the hours that this position will require:
Additional Details
- Manager''s Requested : (No Value)
- Does the position allow for the worker to be virtual/remote? : No
- Shore Options Available for this Position : Onshore Only
- Provide the days of the week and the hours that this position will require: : (No Value)