Process Engineering

2 weeks ago

Bengaluru, India Scalene works Full time

Process development and technology transfer knowledge and expertise in Parenterals. Injectable Exp is preferred.1) Mixing

2) Filling

3) Sterile filtration

4) Large scale autoclave


1.

Performs routine engineering assignments of related tasks which are typically a focused portion of larger projects. These tasks provide experience and familiarization with the engineering staff, methods, techniques, theories, Corporate and division SOP's, policies and projects.

2.

Supervise samples production process and overview logistic aspects.

3.

Document development work including writing specifications for manufacturing or scientific test results.

4.

Ability to solve routine design and engineering tasks with some assistance. Able to solve problems with periodic monitoring. Design study layouts and design of experiments related to new products production process development by applying Quality by Design and Risk-Based approach

5.

Assists in the preparation and participation in technical reviews and responsible for organizing data and preparing appropriate documentation for assigned projects.

6.

Collaborate to the manufacturing process development (i.e. powder filling, solution mixing and filling, process analytical technology, plastics and polymer transformation and characterization) by interacting mainly with the design, quality and manufacturing team,

7.

Identify opportunities to utilize and select new processes technologies to improve existing process or create new processes or products. Identify and experiment these technologies at labs scale to provide recommendations for transfer to manufacturing plants. Manage the relations and communication with the suppliers.

8.

Perform Risk Analysis on manufacturing processes and directly support the validation teams in the plants (pFMEA, Control Plans) Qualifications

•

Ability to discuss normally encountered technical or project management issues, both verbally and in written form.

•

Ability to work as a collaborative team member.

•

Ability to solve routine design, engineering problems with assistance Skills • Bachelors / Masters in Engineering and 3-6 years of related experience (in-house, co-op or acquired outside).

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