Sr. Downstream Processing Technician

Sr. Downstream Processing Technician

The Downstream Processing Technician plays a key role in large-scale biological and chemistry pharmaceutical operations, supporting the manufacture of biologics such as proteins used in therapies for autoimmune and other diseases. In this position, you execute manufacturing batch records, work instructions, and standard operating procedures with a strong focus on accuracy and compliance. You help ensure that all downstream processing activities meet strict cGMP standards while collaborating with a team of scientific and manufacturing professionals in a cleanroom environment.

Responsibilities

• Execute manufacturing batch records, work instructions, and standard operating procedures with a proactive focus on 'right the first time' execution.
• Assist with batch record reconciliation to ensure documentation is accurate, complete, and compliant with cGMP requirements.
• Support all department functions by maintaining suites, supplies, equipment, logbooks, and data in accordance with site SOPs and policies.
• Document all activities to meet cGMP requirements, including daily record reviews, task tracking, and database updates.
• Perform document reviews and revisions to maintain current and accurate procedures and records.
• Actively provide feedback on processes, documentation, and workflow to support continuous improvement.
• Participate and, when needed, lead shift exchanges, one-on-one discussions, and team meetings to facilitate communication and address area needs and changes.
• Engage in lean activities and other improvement initiatives to enhance efficiency and quality in downstream processing.
• Support quality investigations by answering questions, providing detailed feedback, and suggesting process improvements.
• Practice and promote safe work habits, strictly adhering to safety procedures and guidelines in cleanroom and laboratory environments.
• Critically evaluate processes with foresight, identifying potential issues and thinking ahead to prevent deviations.
• Interpret production schedules, prioritize tasks effectively, and complete work according to established timelines.
• Apply aseptic techniques and cleanroom practices during downstream processing operations.
• Handle and operate laboratory and downstream processing equipment used in chromatography and related pharmaceutical processes, as applicable.
• Collaborate with cross-functional teams in manufacturing, operations, and laboratory settings to ensure smooth execution of downstream activities.

Essential Skills

• Bachelor's degree (BS) in a STEM-related field is required.
• Minimum of 2 years of work experience in manufacturing, operations, production, laboratory, or a related technical setting.
• Ability to execute manufacturing batch records, work instructions, and SOPs with high attention to detail and accuracy.
• Familiarity with cGMP requirements and the ability to document activities in compliance with regulatory standards.
• Experience working in cleanroom or aseptic suites and willingness to follow strict aseptic techniques.
• Strong organizational skills with the ability to maintain suites, supplies, equipment, logbooks, and data according to SOPs.
• Ability to interpret production schedules and prioritize tasks to meet operational timelines.
• Capacity to participate in and contribute to meetings, shift exchanges, and team communications.
• Commitment to safe work practices and adherence to safety procedures and guidelines.
• Physical ability to lift a minimum of 25 pounds independently.
• Physical ability to stand for approximately 80% of the shift.
• Ability to meet cleanroom gowning requirements, including wearing full gowning suits and appropriate protective equipment.

Work Environment

This role is based in cleanroom and aseptic suites where strict gowning and contamination control procedures apply. You work in a controlled environment that supports large-scale biological and chemistry pharmaceutical operations, contributing to the production of biologics used in therapeutic products. You must be willing to wear a full gowning suit, including bodysuit, gloves, hair and beard nets, face covers, and safety glasses.

Cleanroom gowning requirements include…