The Role:
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 location level goals and objectives.
Develop annual operating plan and manage budget utilized 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 method engineering functions to enable attainment of current and future business needs.
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 take care of 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.
Coordinate with R&D team to make sure design and development outputs are verified as suitable design for manufacturing and meets expectations of 21 CFR 820 also as other related regulations and standards for the planning transfer from development to manufacturing.
Lead and participate in complex investigations, develop plans and execute tasks to unravel process problems.
Lead implementation of CTQs and CTPs to make sure production processes are efficient controlled; Facility Standard Procedures (FSPs) as well as Work Instruction (WI), Statistical Process Control (SPC), Leader Standard Work (LSW), Gemba Walk, etc. would be enforced as necessary.
Desirable Skills / Qualifications:
Education: academic degree in Chemical Engineering or Polymer Science & Engineering or related.
a minimum of 10 years of operations and/or engineering experience during a cGMP regulated environment.
Demonstrated experience developing and implementing as well as robust manufacturing systems and processes.
Knowledge of FDA Medical Device process validation as well as requirements. Strong process development and optimization skills, with experience in experimental design.
Demonstrated ability to conceive, develop as well as validate ideas resulting in new or improved products, processes, materials and systems.
Ability to steer and facilitate problem solving across teams to realize desired results.
Strong written and verbal communication as well as presentation skills as well as organizational and project management skills.
Strong computer skills, including proficiency with data analysis programs like Minitab, Morestream, SPSS or other statistical as well as analysis software.
Demonstrated understanding of commercial
