Senior Engineer - Process
Location
Chennai | India
Job description
Job Description
- Process Engineer should be able to understand the sequence of finalizing each of the process documents.
- Should be able to understand the project requirements (API / Biotech and Formulations) / philosophies and carryout process activities independently.
- Should have knowledge in Concept / Basic / Detailed Engineering of Life Sciences Projects
- Process inputs for preparation of Mechanical Data sheets. Understands multiple Process Engineering drawings/documents such as Raw materials & utility consumption calculations, Design Basis, Piping Material Specifications (PMS), all List Items, Line List, Valve List, Equipment List, Motor Drives List, Vendor Package PIDs, Equipment Process Data sheets, Noise data sheets, 3-D Model review etc.
- Should have knowledge in good engineering practices and general industry standards such as ASME BPE, ISPE Baseline Guides and ISPE Good Practice Guides.
- Must be familiar of cGMP, Schedule M (India), 21 CFR 210 & 211 (US), EudraLex Volume 4 (EU), ICH, USP and WHO guidelines.
- Should be conversant with sequential activities, cycle time for schedule management towards deliverables to control activities and closeouts in an appropriate manner.
- Coordinate with drafting team and engineering team for process inputs and drawing preparation.
- Work closely with Project team as point of contact for internal / external clients, including understanding their requirements and meeting project expectations.
- Implement quality assurance processes as defined in project quality plan and overall organisational requirements.
- Should have thorough understanding of project interfaces and discipline interdependencies for performing process engineering activities on an assigned project.
- Implement risk assessment, and mitigation strategies related to process to ensure project success.
Qualifications - Graduate in Chemical Engineering / Bio-Technology
- Relevant Life science Engineering experience minimum of 8-15 years
- Expertise in the following is required:
- Bio Pharmaceutical -Upstream and downstream process
- API -Synthetic and Bio Fermentation
- Formulation -Oral solid /suspension
- Fill Finish /Vaccine facility
- Clean Utility water Systems-Potable water, Purified water and WFI
- Asphyxiation Risk Assessment.
- Energy Conservation
About Us Wood is a global leader in consulting and engineering, helping to unlock solutions to critical challenges in energy and materials markets. We provide consulting, projects and operations solutions in 60 countries, employing around 35,000 people.
Diversity Statement We are an equal opportunity employer that recognises the value of a diverse workforce. All suitably qualified applicants will receive consideration for employment on the basis of objective criteria and without regard to the following (which is a non-exhaustive list): race, colour, age, religion, gender, national origin, disability, sexual orientation, gender identity, protected veteran status, or other characteristics in accordance with the relevant governing laws.
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