Process Technician, Production (USFDA - GMP Plant)

Are you a skilled professional with expertise in pharmaceutical production? Our client, a renowned pharmaceutical company, is currently looking for a qualified candidate to fill the Process Technician, Production role. This position offers the chance to work in a cutting-edge USFDA-GMP Oral Solid Dosage (OSD) environment where innovation and compliance are at the forefront. This role will be based in Nilai, Negeri Sembilan.

Key Responsibilities:

• Operate critical equipment such as Granulation Suites, Fluid Bed Processor, Roller Compactor, Compression (Fette 3030P and Bilayer processes), Coating, Encapsulation, Blister Packing, Bottle Packing, and Serialization machines.
• Ensure compliance with 21 CFR Part 11, cGMP, and regulatory standards while meeting production targets and maintaining product quality.
• Troubleshoot, manage recipes, and oversee manufacturing and packing processes.
• Conduct quality checks, perform cleaning, and complete accurate documentation within a GMP framework.
• Train and mentor production trainees and operators.
• Maintain a compliance-ready state for USFDA inspections.

Requirements:

• Education: Technical Certificate in Science, Pharmacy, Pharmaceutical, Engineering, or related fields.
• Experience: 5–10 years in the Pharma OSD industry; knowledge of other dosage forms is a plus.
• Technical Expertise: Skilled in Compression, Coating, and Encapsulation processes.
• Proficiency in Microsoft Office Suite and strong interpersonal skills.
• Familiarity with USFDA regulations and a safety-oriented mindset.

Advantages:

• Opportunity to work in a state-of-the-art facility with advanced equipment and processes.
• Collaborate with a team of professionals committed to compliance, safety, and operational excellence.
• Gain valuable experience in an industry-leading environment with global regulatory exposure.

Salary : between RM6,500 to RM7,500