Provides process engineering and controls support
Performing process characterization and optimization using designed experiments, and problem solving and decision making tools.
DUTIES & RESPONSIBILITIES-
Designs comprehensive engineering activities to develop and implement effective, high quality processes and design guidelines for dissemination through out the division. Designs experiments and capability studies, develops process specifications, and designs and procures process tooling. Analyzes new processes and equipment with the intent of achieving continuous improvement of present methods. Communicates and monitors process and material quality targets. Measures performance to targets and implements remedial actions as instructed. Develops
RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS
o Responsible to work in conjunction with Manufacturing, Quality Assurance, Engineering, Regulation and Validation departments to support and troubleshoot existing operations, provide recommendations for process improvements.
o Participates and leading meetings related to changes in processes, process improvements, and so on
o Providing manufacturing subject matter expertise to support Process validations and Process Qualifications and process changes.
o Connect and work in conjunction with external suppliers for product related manufacturing equipment and issues troubleshooting.
o Support regulatory audits and requests
EXPERIENCE AND EDUCATION
o University/Bachelors Degree or Equivalent (preferably science degree)
o Generally Requires 1-3 Years Work Experience
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.
o Develops systems and processes regarding collection of data, analysis and reporting of production process trends, for example: Yields, OOS, and Deviations.
o Conducts process related root cause investigations and management of process related CAPA.
o Performs on-going manufacturing process evaluation, identification of potential manufacturing risks and proposal of preventive actions with regards to process changes.
o Reviews technical reports and other sources of information to ensure that validations and procedures are consistent with current industry, regulatory requirements, and current technology.
o Participates in validation projects, programs and activities held in the company as required
o Provides guidance on aspects of validations and qualifications.
o Conducts risk assessment of manufacturing changes to support appropriate controls and mitigation strategies.
o Evaluation and ownership of process related Change Control.
o Review of manufacturing procedures for compliance with quality standards and regulations and implementation of improvement opportunities
ADDITIONAL POSITION REQUIREMENTS
o Ability to work in flexible hours when required
o Writing capabilities (English)