Production Operator – Manufacturing Biotech Associate (Level 02)

About the role

The Manufacturing Biotech Associate (BTA) Level 02 supports biologic drug substance manufacturing in a state‑of‑the‑art GMP facility. Working on both clinical and commercial biologics, the role involves operating automated equipment, handling upstream and downstream processes, and ensuring safe, efficient, and compliant production.

Key responsibilities

• Operate manufacturing equipment according to electronic batch records, sampling plans, and SOPs.
• Perform upstream and downstream activities such as inoculation, cell culture, filtration, and purification.
• Set up and prepare single‑use systems and equipment between production runs.
• Maintain strict adherence to GMP, EHS, contamination control, and regulatory standards.
• Complete manufacturing documentation accurately and on time.
• Participate in shift handovers, production meetings, and team discussions.
• Escalate operational, safety, or compliance issues to supervisors.
• Support continuous‑improvement projects using Lean Six Sigma methodologies.
• Help achieve KPIs related to safety, production, compliance, training, and equipment effectiveness.
• Create and update SOPs and work instructions to maintain regulatory compliance.

Required profile

• Level 6 qualification in Science, Engineering, Biotechnology, Biochemistry, Pharmaceutical Science or a related discipline (preferred).
• Minimum 2 years of experience in a GMP manufacturing environment or equivalent.
• Strong teamwork, communication, attention to detail, and problem‑solving mindset.
• Ability to work independently and within cross‑functional teams in a fast‑paced environment.

Required skills

• Emerson DeltaV
• PAS‑X
• Electronic batch record systems
• Single‑use technologies
• Upstream and downstream processing operations
• Contamination control and batch release knowledge
• Lean Six Sigma methodologies