Industry: Medical Devices

Duration: 07 Months (++Possibility of Extension)

Purpose:

We are seeking an experienced Pharmaceutical and Manufacturing Technician with a strong background in sterile compounding, cleanroom operations, and medical device production. The ideal candidate will bring expertise in aseptic processing, protein purification, chromatography, and automated manufacturing systems, while ensuring strict compliance with cGMP, GDP, FDA, and other regulatory standards.

Key Responsibilities:

• Perform sterile compounding, aseptic processing, protein purification, chromatography, and related manufacturing activities.
• Operate and troubleshoot automated systems, cleanroom equipment, and laboratory instrumentation.
• Ensure compliance with cGMP, GLP, CLIA, HIPAA, and FDA regulatory requirements.
• Support production operations, including material transfer, formulation, filtration, labeling, packaging, and shipping.
• Collaborate with cross-functional teams (scientists, engineers, quality, and maintenance).
• Assist in quality assurance, inventory management, and documentation of batch records/logbooks.
• Provide training and guidance to junior technicians/operators.
• Conduct environmental monitoring, maintain cleanroom standards, and follow strict safety protocols.

Required Qualifications:

• Bachelor’s degree in Molecular & Cellular Biology, Biochemistry, Biotechnology, or related field.
• 3–5+ years of hands-on experience in pharmaceutical, biotech, or medical device manufacturing.
• Strong knowledge of aseptic technique, cleanroom operations (ISO 5–8), and cGMP.
• Familiarity with protein purification, chromatography, immunoassays, and automated lab/manufacturing systems.
• Ability to troubleshoot equipment, perform routine maintenance, and support process automation.
• Excellent organizational, time management, and communication skills.

Preferred Qualifications:

• Certificate in Biotechnology or related certifications.
• Experience with mammalian cell culture, rtPCR/qPCR, or clinical laboratory techniques.
• Knowledge of chromatography systems, Delta V, and other process control systems.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)