BriefCase
BriefCase

Staff Process Engineer Job in Maitreya Consultants

Staff Process Engineer

Maitreya Consultants 4+ weeks ago
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Job Summary
  • Leading, coordinating and executing the recurring validation activities according to validation master plan.
  • Leading of process characterization & development activities in projects and initiatives
  • Creating validation strategies, test plans, validation specifications, protocols, and reports
  • Documenting changes of methods, processes, and material in ADAPTIV (MVI)
  • Leading the equipment qualification
  • Planning, coordination, monitoring and evaluation of manufacturing equipment & process validation activities
  • Training of employees in validation specifications, test plans, test methods, etc.
  • Supporting the selection of processes / machines, considering the requirements of project and production as well as investment and cost aspects.
  • Ensuring an effective process risk management (FMEA) carrying out process risk analysis process participation in product risk analysis
  • Developing manufacturing processes under application / considering methodological concepts (Six Sigma, Lean).
  • Supporting the root cause identification and implementation/documentation of corrective measures during the stabilization phase of a product / process development project.
  • Taking over of co-ordination and project management tasks for the Aurangabad site if no project manager is associated with the project
  • Ensuring process optimization within the stabilization phase of assigned project
  • Engages to comply with ISO and FDA requirements.
  • Ensuring compliance to the Quality system requirements.
  • Utilizing problem solving skills and statistical techniques to support product / processes controls that are aligned with the overall quality and business vision.
  • Assuring that engineering department is appropriately run in a safe, clean and environmentally sound manner.
  • Developing and analyzing statistical data and machine specification so as to determine present standards and establish proposed quality and reliability expectancy of finished product
  • Assisting in engineering budget preparation, goal tracking and in the business planning process.
  • Supporting for NCR s investigation and performs trend analysis and report to Management.
  • Ensuring for training / compliance of GMP as per FDA guidelines and site procedures and Policies and on the job training.
  • Participating in audits and gap assessments in support of the internal audit program and FDA readiness.
  • Partnering with operations in the investigation / correction of process failure.
  • Developing safety culture in the engineering function.
  • Responsible for updating the Record retention schedule for Engineering department every year.
  • Observes & promotes all regulatory requirements as defined per applicable regulations, rules & procedures established by the Company, and notified any violation or deviation to the immediate supervisor or appropriate authority.
  • Complies with all training requirements to perform duties of the job.
  • Ensure adherence/compliance to Records Management policies and procedures, as applicable
  • Authorized for approval of Returnable Gate Pass, Invoices
  • Authorized for approval as per delegation process.
  • Responsible for communicating business related issues or opportunities to next management level.
  • Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Performs other duties assigned as needed
  • As IOSS area owners(if applicable) need to do following activities
Experience Required :

6 to 10 Years

Vacancy :

2 - 4 Hires

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