Designation: Deputy Manager
Level: 7 - II
Job Location: Bangalore
The Company
Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene s 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.
Position Summary:
We are seeking a highly skilled and motivated
Process Automation Engineer
with a strong background in biopharmaceutical process design and/or manufacturing
. The ideal candidate will bring hands-on expertise in automation systems
, particularly within Upstream operations
and add on experience in Downstream operations
(chromatography, ultrafiltration/diafiltration, nanofiltration). This role offers the opportunity to work on cutting-edge projects in process automation, recipe management, and control system design using advanced platforms and will extend to digital transformation
Functional Responsibilities:
- Design, develop, and implement automation solutions for
Upstream and downstream operations
- Develop
process control strategies
in compliance with ISA S88 standards
for batch process automation - Create, configure, and validate
recipe management systems
for complex biopharma operations - Design and implement
PLC-based control systems
using platforms such as Siemens WinCC
, PCS7
, or similar - Configure and maintain
DCS platforms
, including Siemens PCS7
and/or DeltaV
from Emerson - Collaborate with cross-functional teams including process engineering, validation, manufacturing, and quality
- Troubleshoot and resolve automation-related issues during project execution or manufacturing daily operations
- Author and review automation documentation including design specifications, FRS,SDS, HDS, URS, FAT, SAT, and validation protocols
- Implementing minor and major expansion projects on site and changes targeting optimisation as part of the operational support
Primary Responsibilities:
- Project Ownership: Accountable for the successful execution of projects from initiation through completion, ensuring all deliverables meet client expectations and regulatory standards.
- Quality Assurance: Responsible for ensuring that all processes comply with cGMP and other regulatory requirements, thereby safeguarding product quality and patient safety.
- Client Satisfaction: Ensure high levels of client satisfaction through effective communication, timely updates, and proactive problem-solving.
- Compliance and Risk Management: Identify and mitigate risks associated with technology transfer, ensuring that all operations are compliant with internal and external guidelines.
- Develop and validate process maps and models in collaboration with cross-functional teams.
- Adapt to additional tasks and responsibilities as assigned, demonstrating flexibility and a proactive approach.
Education
- B.Tech/M.Tech in Industrial Process Engineering, Automation Engineering, Instrumentation & Electrical Engineering, Chemical Engineering or related fields.
- 7-10 years of relevant industry experience in
biopharmaceutical automation
(process design, commissioning, or manufacturing support) - In-depth knowledge of
biotech manufacturing processes
, with specialization in Upstream automation,
not limited to process including software writing and IT & infrastructure - Experience with
PLC and SCADA/DCS platforms
: Siemens WinCC, PCS7, DeltaV, or comparable systems - Proficient in
batch process control
, recipe creation as per ISA/S88 is a must - Strong understanding of
instrumentation
, P&IDs
, control strategies, and process control hardware/software integration - Knowledge of
GAMP5
, 21 CFR Part 11 compliance
, and other regulatory guidelines - Hands-on experience in project executions including qualification phase (IQ/OQ/PQ) and on-floor operations
- Excellent communication and documentation skills
Preferred Attributes:
- Experience with single-use technologies (SUT) and Stainless-Steel technologies in bioprocessing
- Prior involvement in facility design or greenfield/brownfield projects
- Experience working with
digital plant systems
or in digital transformation
initiatives in biopharma - Exposure to
data historians
, automation analytics
, and real-time monitoring systems