Production Associate

Position Summary

The USP Operator supports the manufacturing of biopharmaceutical Drug Substance in a GMP-regulated environment. The role is responsible for executing upstream processing activities including inoculum expansion bioreactor operation sampling process monitoring cleaning activities and GMP compliant documentation. This position is designed for entry-level candidates seeking to develop technical expertise in mammalian cell culture manufacturing within a Contract Development and Manufacturing Organization (CDMO).

Key Responsibilities

Manufacturing Operations

• Perform upstream manufacturing activities according to GMP requirements approved procedures and batch records
• Execute inoculum expansion and mammalian cell culture operations
• Assist in the operation and monitoring of single-use bioreactors up to the 2000L scale
• Perform process sampling and basic analytical testing according to procedures
• Monitor process parameters and report deviations or unusual observations
• Support setup assembly disassembly cleaning and preparation of process equipment
• Ensure manufacturing areas remain inspection-ready and compliant with GMP requirements

Documentation & Compliance

• Complete batch records and GMP documentation accurately and contemporaneously
• Adhere to Standard Operating Procedures (SOPs) work instructions and safety requirements
• Support deviation investigations by providing factual information and documentation
• Participate in training programs and maintain required qualifications
• Follow data integrity principles and good documentation practices (GDP)

Continuous Improvement

• Contribute to operational excellence initiatives
• Identify opportunities to improve safety quality compliance and efficiency
• Participate in team meetings and knowledge-sharing activities

Key Requirements

Education

• Completed vocational training apprenticeship technician qualification or bachelors degree in Biotechnology Biology Bioprocess Engineering Pharmaceutical Technology Chemical Engineering or related scientific discipline

Preferred Experience

• Initial practical experience through internships apprenticeships laboratory work or industrial placements in biotechnology or pharmaceutical manufacturing with exposure to cell culture techniques Bioreactor systems Single-use technologies GMP-regulated environments
• Foundational knowledge of Mammalian cell culture Upstream processing Bioreactors Aseptic techniques Process monitoring systems

Behavioral Competencies

• Strong attention to detail Commitment to quality and compliance Team-oriented mindset Reliable and accountable work ethic Effective communication skills Continuous learning attitude Safety-conscious behavior Ability to work in a fast-paced manufacturing environment