Process Engineer

Sun Pharmaceutical Industries Ltd•Chattanooga, TN

16d•$103,000 - $114,500•Onsite

About The Position

This position will provide engineering designs and recommendations for assigned processes and new technologies to develop the most cost-effective solutions for manufacturing.

Requirements

Bachelor's degree in Chemical Engineering, or related engineering discipline.
Minimum of 5 years of experience working in a regulated manufacturing environment.
Demonstrated ability to effectively manage multiple priorities, projects, and deadlines in a fast-paced environment.
Ability to effectively communicate technical concepts and present ideas to all levels of the organization, including leadership.
Working knowledge of business operations, budgeting processes, production planning, and key business performance metrics.
Demonstrated ability to operate effectively and make sound decisions in a fast-paced manufacturing environment.
Proven ability to partner effectively with Quality, Operations, Technical Services, and other cross-functional teams to achieve business objectives.
Demonstrates an understanding of the broader business environment and how engineering decisions support operational and organizational success.

Nice To Haves

Developing and optimizing centrifugation (isolation), drying, milling, and powder-handling processes from pilot scale through commercial manufacturing.
Designing equipment, operating conditions, and control strategies to achieve target particle size, moisture content, residual solvent levels, purity, bulk density, tapped density, and flowability.
Demonstrated ability to lead projects, influence cross-functional teams, drive process improvements, and provide technical guidance within a manufacturing environment.
Minimum of 5 years of experience operating within FDA-regulated and GMP manufacturing environments.
Experience working within DEA guidelines and regulatory requirements.
Experience working within FDA-regulated quality systems, including change control processes.
Experience with Distributed Control Systems (DCS) and process automation platforms.

Responsibilities

Prepare, review, approve and distribute the instructions for the production of intermediates or APIs according to written procedures.
Produce APIs and intermediates according to preapproved instructions.
Review all production batch records and ensure that these are completed and signed.
Report and evaluate all production deviations and ensure that all critical deviations are investigated, with conclusions recorded.
Ensure that production facilities are clean and disinfected.
Ensure that all necessary calibrations are performed and documented.
Maintain the premises and equipment, with records kept.
Ensure that validation protocols and reports are reviewed and approved.
Evaluate proposed changes in product, process, or equipment.
Ensure that new and modified facilities and equipment are qualified.
Review and analyze manufacturing needs, formulate solutions, and implement changes to optimize manufacturing processes.
Manage assigned projects to ensure completion on time, within budget, and in accordance with design parameters.
Provide training for API processes.
Perform other duties as assigned.