Team Member - DS Instrumentation

Experienced Team member to handle Instrumentation & Automation (I&A) function in Drug Substance manufacturing plant. This role plays a critical part in ensuring the smooth operation, efficiency, and regulatory compliance of our biopharmaceutical manufacturing processes. To join a team of technicians responsible for maintaining, troubleshooting, and optimizing a complex network of instrumentation and automation systems.

Responsibilities:

• Implement strategies for the preventative maintenance of all I&A equipment within the Drug Substance manufacturing area.
• Perform qualification of I&A equipment according to cGMP and regulatory requirements.
• Troubleshoot and resolve I&A system malfunctions, ensuring minimal disruption to production timelines.
• Work collaboratively with other engineering personnel, production teams and quality assurance to identify opportunities for process optimization through automation.
• Stay current on advancements in I&A technology relevant to biopharmaceutical manufacturing.
• Manage and maintain technical documentation for all I&A systems.
• Prepare and participate in audits and inspections related to I&A systems.
• Ensure adherence to all safety regulations and procedures within the manufacturing plant.

Qualifications

• Bachelor's degree in Engineering (in instrumentation/electronics & communication/ electrical/Computer Science) or a related field.
• Minimum 5 years of experience in a biopharmaceutical or similar aseptic manufacturing environment with a focus on I&A.
• Proven experience in a technical environment.
• Strong understanding of cGMP regulations and GAMP 5 guidelines.
• In-depth knowledge of biopharmaceutical manufacturing processes and equipment.
• Experience with common biopharmaceutical manufacturing automation systems (e.g., DCS, SCADA, PLC).
• Troubleshooting and problem-solving skills.
• Strong communication, interpersonal, and collaboration skills.
• Ability to prioritize and handle multiple tasks in a fast-paced environment.

Resident Skills
. Audit Management
. Compliance Management
. Lean Methodologies
. Root Cause Analysis
. Workplace Safety
Behavioural Skills
. Proactive Safety Awareness Demonstrates vigilance in identifying hazards and enforcing safety protocols during maintenance activities.
. Process Discipline and Documentation Maintains accurate records, follows SOPs, and ensures compliance with GMP/cGMP and statutory standards.
. Collaborative Problem Solving Works effectively with cross-functional teams to troubleshoot issues, implement solutions, and drive continuous improvement.
Critical exposures
. Experience in performing calibration of laboratory instruments, manufacturing equipment, and utilities in compliance with cGMP and regulatory standards is desired. Experience in Pharmaceutical, Biotechnology, Medical Devices, Life Sciences industry is desired
. Exposure to developing and managing calibration schedules to ensure timely and compliant calibration of critical equipment is preferred.
. Experience in documenting calibration activities, including calibration certificates, deviation handling, and audit readiness, is desired.