Lab Tech II

Responsibilities

• Collaborate on projects supporting manufacturing process areas to achieve process efficiencies.
• Gather and analyze process data using statistical process control methodology.
• Develop action plans to increase process robustness, prevent product loss, and control quality impact.
• Participate in process performance monitoring such as Track & Trend.
• Provide technical support in resolving shop floor situations and executing assigned tasks.
• Collaborate on investigations by following a structured problem-solving approach and employing sound, scientific principles.
• Generate technical justification to support and/or document process deviations/investigations and determine their impact on product quality, yield, and product registration.
• Part of cross-functional team responsible for implementing site projects/initiatives leading to process remediation.
• Member of smaller teams working on short-duration projects within larger projects.
• Collaborate on the implementation of process validation for operational changes, new raw materials, and introduction of new processes/technology.
• Generate technical justification to determine the impact of changes and develop protocols/reports/manufacturing documents supporting their execution.
• Assist in the execution of experimental, demonstration, and validation lots.
• Maintain up-to-date product process documentation and ensure compliance with applicable procedures and regulations.
• Write justification memos and scientific reports of quality controls and manufacturing documents.
• Provide scientific and technical support during regulatory audits and agency inspections.
• Demonstrate accountability and responsibility for EHS performance and compliance through active participation and support of the EHS program.

Qualifications

• BS or MS or equivalent education in Engineering-Chemical, Chemical, Bio-chemical, or other relevant scientific field.
• 3-5 years' of technical experience in Process/Manufacturing/Project Engineering/Laboratory or similar role.
• Technical knowledge in fundamentals of pharmaceutical process (sterile/aseptic product manufacturing).
• Effective verbal and written communication skills in English.