Manufacturing Technician

Role Overview

The Manufacturing Technician plays a crucial role in supporting manufacturing activities throughout the startup, commissioning, qualification phases, and ongoing production within a pharmaceutical or regulated manufacturing facility. This position involves adherence to current Good Manufacturing Practice (cGMP) standards while collaborating with multiple departments to ensure smooth, compliant production processes.

Key Responsibilities

• Assist during facility startup, including equipment commissioning, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities.
• Set up, check, and operate manufacturing equipment and perform trial and engineering runs to facilitate qualification batches.
• Execute manufacturing tasks in alignment with approved standard operating procedures (SOPs), batch records, and GMP guidelines.
• Manage equipment setup, line clearance, material handling, cleaning, and changeovers to uphold production efficiency and safety.
• Monitor process parameters and equipment conditions, perform in-process checks, and ensure comprehensive documentation of all manufacturing data.
• Identify and promptly report any abnormalities, deviations, or safety concerns during manufacturing operations.
• Maintain accurate and timely GMP documentation including batch records, logbooks, and electronic records, following Good Documentation Practices.
• Provide information and data to support process validation, troubleshooting, and continuous improvement initiatives such as 5S, Lean Manufacturing, and workplace enhancements.
• Ensure compliance with Environmental, Health & Safety (EHS) protocols, use appropriate personal protective equipment (PPE), and foster a clean, organized workspace.
• Protect product quality by adhering to approved procedures and escalating potential quality risks.
• Complete required training to maintain qualifications and assist in onboarding new team members.
• Engage in effective team communication through shift handovers and meetings, collaborating with Manufacturing, Quality, Engineering, and Technical Services departments.

Qualifications and Experience

• Possession of a Diploma or technical qualification in Pharmaceutical Sciences, Biotechnology, Chemical Engineering, Manufacturing, Mechanical Engineering, or related fields.
• One to three years of experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments is preferred.
• Familiarity with GMP manufacturing processes, cleanroom operations, equipment handling, and production systems is advantageous.
• Understanding of cGMP, GDP, safety standards, and regulatory manufacturing practices.
• Experience handling batch documentation, executing SOPs, and operating manufacturing systems.
• Strong attention to detail with the capability to follow written protocols accurately.
• Capability to work within a cleanroom and participate in shift-based operations.
• Effective communication and teamwork skills across cross-functional groups.