Ecocareers ยท 3 months ago
Process/Validation Engineer
Branchburg, NJ
Full-time
Onsite
Mid Level
3+ years expEcocareers is a company seeking a Process/Validation Engineer to support engineering production and process improvements. The role involves equipment qualification, validation processes, and ensuring compliance in the medical device or pharmaceutical industry.
Staffing & Recruiting
Responsibilities
Process and Cleaning Validation Experience
Equipment Qualification (IOQ/PQ)
Quality System Experience (Veeva, Track wise, Compliance Wire)
Medical Device or Pharmaceutical Experience Required. Preferred Medical Device with 3-5 Years
Statistical Analysis (Minitab or JUMP)
The Process/Validation Engineer is responsible for providing engineering production support including:
Implementing process and technology improvements
Process and Cleaning Validation
Equipment Qualification
Collecting, monitoring, analysing, 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
Responsible for the initiation and follow-through of the change control processes
Qualification
Required
Bachelor's degree in engineering, science or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 3-5 years of significant process engineering and/or operational experience in Medical Device or Pharmaceutical industry. Additional post-graduate education may contribute towards the desired years of experience
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
Excellent Technical writing skills and attention to fine detail
Understanding of AATB, FDA, ISO, ISPE, and other regulatory guidelines including understanding of the various regulations and guidelines such as FDA 21 CFR 11, 820 and 1270, ISO 11737, 13485 and 14644, and others, as required
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, Client PowerPoint, Project, and Visio
Time management skills and follow-through skills with the ability to work on and manage multiple tasks with tight deadlines
Strategic thinking and planning
Excellent organizational skills
Excellent oral and written communication skills
Preferred
Medical Device or Pharmaceutical Experience Required. Preferred Medical Device with 3-5 Years
Statistical Analysis (Minitab or JUMP)
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase