Aseptic Manufacturing Sr. Technician 2nd Shift 1:00pm-9:30pm

What You'll Do

The Sr. Aseptic Technician performs routine and non-routine activities and procedures required for the manufacture and filling of aseptic products. This role follows established procedures in the execution of daily activities and uses judgment in resolving basic issues or making recommendations.

How You'll Contribute

• Operates production equipment according to Standard Operating Procedures (SOPs), Batch Records, Manufacturing Directions (MD), and Manufacturing Operating Procedures (OPM).
• Executes all procedures associated with aseptic fills (transfer, set-up, sanitization, autoclaving, process simulation, etc.).
• Performs scheduled cleaning and sterilization of equipment.
• Supports changeover activities.
• Troubleshoots and resolves process-related issues.
• Initiates work orders.
• Reviews manufacturing documentation for compliance.
• Coordinates sample preparation and testing.
• Records data into Batch Records, log books, and OPMs.
• Documents all work activities according to Good Documentation Practices and recommends document revisions.
• Reports procedural deviations and nonconformance to management.
• Assists Lead Technician in quality system generation, reviewing log books and non-critical forms, and maintaining floor metrics.
• Maintains current training on all assigned procedures, including read-and-understood, skills development, and classroom training activities as required.

What It Takes

The position works on assignments that are moderately difficult, requiring judgment in resolving issues or making recommendations. The Sr. Aseptic Technician normally receives little instruction on daily work and general instructions on newly introduced assignments.

What You Bring

• High school diploma or GED, or equivalent experience.
• 4–6 years of related experience in a cGMP manufacturing environment.
• Ability to work flexible hours to complete work activities.
• Strong written and verbal communication skills.
• Proficiency in computer skills and Microsoft Office applications.
• Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas and wear personal protective equipment such as safety glasses/goggles, gloves, and safety shoes.
• Ability to lift, pull, or push equipment requiring up to 25–50 lbs. and stand for up to 6 hours in a production suite.
• Ability to climb ladders and work platforms.
• Ability to work around chemicals including alcohols, acids, and bases.
• Ability to work flexible hours to complete work activities.

Nice to Have

• Manufacturing experience in the medical device industry.
• Experience working in a clean room or using aseptic technique.
• Experience using commercial-scale automated equipment.
• Experience with ERP systems, preferably SAP.