Job Purpose: Participates in the design of a process unit, including establishing process design basis, development of process options and optimization of selected design. This position focuses on the Pharmaceutical, Biotech based food/food ingredient sectors.

Job Description: The Process Engineer will be executing process design engineering activities for the capital and operational improvement projects of the plant. This position requires participation in the concept development, design, fabrication, commissioning and qualification of process systems in a GMP environment. This position is also a participant with the production team and the R&D team in the development and / or technology transfer of new solutions and modifications to the existing manufacturing process systems while adhering to established regulatory compliance requirements.

Role and Responsibilities :

- Author, review and approve all technical documents throughout the equipment/system lifecycle from commissioning and qualification through decommissioning and retirement.

- Execution and documentation of functional tests, protocols and qualifications for new systems.

- Responsible for the incorporation and satisfaction of user requirements and quality requirements within design solutions.

- Oversee Factory Acceptance Tests(FAT) and Site Acceptance Tests(SAT) for new equipment

- Engage with the Original Equipment Manufacturers(OEMs) for establishing the operating performance of the equipment

- Complete investigations of process system deviations and implement corrective and preventive actions as required mitigating future recurrence.

- Manage relevant engineering activities and prioritize work to ensure site and project timelines are met. This will include direct assistance on the production floor.

- May be required to work with service providers and contractors while they are on-site performing maintenance, repairs and projects on buildings, systems and equipment.

- Interface with other departments and sites regarding special projects and quality issues as required.

- May be called upon to speak to regulatory agencies regarding manufacturing systems and equipment.

- Liaise with Quality Assurance and Regulatory Affairs and prepare/review documentation required for regulatory submissions and change controls.

- Support the Engineering Drawing Management program.

- The above statements are intended to describe the general nature of work. It is not an exhaustive list of all duties, and other duties may be assigned.

Job Experience Required :

- 5 or more years of experience in applied process design engineering relating to biological production.

- Extensive knowledge of GMP requirements and commissioning and qualification required. Formal training in bioreactors and/or typical separation and purification technology applications in biologicals manufacturing is an advantage.

- Individual with experience must have knowledge of unit operations typically used in biotech and biotech based food/food ingredient manufacturing such as bulk manufacturing, upstream fermentation and downstream operations, steam(SIP) and clean (CIP) in place.

- Well versed in typical process engineering documentation, such as Process Flow Diagrams (PFD- s), Piping and Instrumentation Diagrams (PID- s), User Requirement Specifications (URS), and Equipment Design Specifications.

- Develop the process design basis (including mass balance, heat balance, sizing and selection of equipment and instrumentation for control of robust processes) considering process/equipment/human safety as an integral part of the design development

- This position requires strong analytical skills (ability to apply engineering principles to design), hands-on troubleshooting skills and the capability to utilize AutoCAD and analysis software.

- Must be able to critically evaluate data summaries and conclusions.

- Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required

Qualifications: Minimum BE/B.Tech. in Biochemical or Chemical Engineering from reputed Institute

Desirable :

- Modeling and simulation of biotech manufacturing unit operations and processes (SuperPro Designer, Schedule Pro, CFD).

- Quality Systems experience

- Experience in using SAP is an advantage.

Work Experience: Minimum 5 years- experience in key roles in Process Engineering in biotech/ biotech based manufacturing industries

Essential Attributes :

- Ability to critically evaluate and troubleshoot complex problems is essential

- Ability to effectively communicate, interact and collaborate with internal and external team members is essential.

- Strong hands on leadership and management skills

- Well-organized and detailed oriented professional, with strong verbal and written communication skills

- Exposure to International standards and regulatory requirements like EHEDG,3A, USFDA, FDA 21CFR etc. pertaining to Food, Nutraceuticals and Pharma

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