Manufacturing Technology Manager / ThailandClick here to shortlist this job 1-CLICK Apply With Employer or Register Now
|Duration:||Permanent - 1 month|
* Manage the Manufacturing Technology, process engineering team (both sustaining and project).
* Develop and implement the departmental goals and objectives to be in line with the site level goals and objectives.
* Develop annual operating plan and manage budget used in Manufacturing Technology department.
* Allocate resources to facilitate attainment of project goals within established timelines and budgets; monitor execution of project plans.
* Lead organizational development and improvement for the process engineering functions to enable attainment of current and future business needs.
* Create and maintain an environment of innovation and continuous improvement, focusing on quality, cost reduction, process development, and supply chain optimization.
* Develop master validation plans to identify processes to be validated, the schedule for validations, interrelationships between processes requiring validation and timing for revalidations.
* Define, develop and drive the process validation strategies across the different teams applying a standard process for installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ).
* Ensure compliance with all government and company regulations, policies, Facility Standard Procedures (FSPs), and Work Instructions (WI) in support of quality, regulatory compliance, health, safety and environmental requirements.
* Work as a strategic partner with all other departments to maintain efficient communication and ensure alignment to site and company level objectives and project prioritization.
* Provide direction and technical support in identifying continuous improvements to manufacturing operations and implementing new technologies.
* Provide direction in supporting the needs of manufacturing areas by addressing requirements for quality standards, ensuring compliant documentation, and pursuing improvements in capacity, product availability and cost.
* Coordinate with R&D team to ensure design and development outputs are verified as suitable design for manufacturing and meets expectations of 21 CFR 820 as well as other related regulations and standards for the design transfer from development to manufacturing.
* Lead and participate in complex investigations, develop plans and execute tasks to solve process problems.
* Use the input from Nonconformance (NC), Complaint investigations, Audit Observations and Corrective and Preventive Actions (CAPA) as well as other Process/Product Quality Trends to drive continuous improvement.
* Lead implementation of CTQs and CTPs to ensure production processes are efficient controlled; Facility Standard Procedures (FSPs), Work Instruction (WI), Statistical Process Control (SPC), Leader Standard Work (LSW), Gemba Walk, etc. would be enforced as necessary.
Desirable Skills / Qualifications:
* Education: Master's degree in Chemical Engineering or Polymer Science & Engineering or related.
* At least 10 years of operations and/or engineering experience in a cGMP regulated environment.
* Demonstrated experience developing and implementing robust manufacturing systems and processes.
* Knowledge of FDA Medical Device process validation requirements.
* Strong process development and optimization skills, with experience in experimental design.
* Demonstrated ability to conceive, develop and validate ideas leading to new or improved products, processes, materials and systems.
* Ability to lead and facilitate problem solving across teams to achieve desired results.
* Strong written and verbal communication and presentation skills.
* Strong organizational and project management skills.
* Strong computer skills, including proficiency with data analysis programs like Minitab, Morestream, SPSS or other statistical analysis software.
* Demonstrated understanding of industrial