Downstream Processing Technician

This role supports the manufacture of biologics such as proteins used in pharmaceutical products for conditions like autoimmune diseases. The Downstream Processing Technician III focuses on flawless execution of manufacturing batch records, work instructions, and standard operating procedures (SOPs) in a cGMP-regulated, cleanroom environment.

Responsibilities

• Execute manufacturing batch records, work instructions, and SOPs with a proactive focus on accurate, ‘right the first time’ completion.
• Assist with batch record reconciliation to ensure documentation is complete and accurate.
• Support all departmental functions by maintaining suites, supplies, equipment, logbooks, and data in accordance with site SOPs and policies.
• Document all activities to meet cGMP requirements, including completing document reviews, revisions, daily record reviews, and updating tasks and databases.
• Actively provide feedback on documentation, processes, and workflows to support continuous improvement.
• Participate in and, when needed, lead shift exchanges, one-on-one discussions, and meetings to support area needs and respond to changes, including lean activities.
• Support quality investigations by answering questions, providing feedback, and suggesting process improvements.
• Practice and promote safe work habits and adhere to all safety procedures and guidelines.
• Critically evaluate processes with foresight, identifying potential issues and opportunities to improve efficiency and compliance.
• Interpret production schedules, prioritize tasks appropriately, and complete work according to schedule requirements.
• Maintain aseptic technique and cleanroom discipline at all times while performing downstream processing activities.
• Contribute subject matter expertise on downstream processing steps, as applicable, to support team performance and training.
• Collaborate effectively with cross-functional teams in manufacturing, operations, and laboratory settings to meet production goals.

Work Environment

This role is based in a cleanroom, aseptic suite environment where strict gowning and contamination control procedures are required. Team members wear full gowning suits, including bodysuits, gloves, hair and beard nets, face covers, and safety glasses. Cleanroom gowning requirements include wearing Tyvek garments and Nitrile and/or Latex gloves. Certain personal items and products are not permitted in the cleanroom, including makeup, jewelry, nail polish, cologne or perfume, and scented lotions or hair care products.

The position initially trains Monday through Friday on a day schedule for approximately 4 to 6 weeks, then transitions to a rotating two-week schedule:

• Week 1: off Sunday, work Monday–Wednesday, off Thursday–Friday, work Saturday
• Week 2: work Sunday, off Monday–Tuesday, work Wednesday–Friday, off Saturday

The environment is highly regulated, focused on safety, quality, and cGMP compliance, and offers exposure to large-scale biological and chemistry pharmaceutical operations producing biologics used in pharmaceutical products.

Schedule

Rotating two-week schedule after initial 4–6 week day-shift training period:

• Week 1: off Sunday, work Monday–Wednesday, off Thursday–Friday, work Saturday
• Week 2: work Sunday, off Monday–Tuesday, work Wednesday–Friday, off Saturday

Pay

$30.00 - $30.00/hr.

Benefits

Eligibility requirements apply to some benefits and may depend on job classification and length of employment. Benefits are subject to change and may include:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital insurance
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

About the role

This is a Contract to Hire, fully onsite position based in Saint Louis, MO.