Manufacturing Associate I

About the role

Executes routine unit operations in Manufacturing Assembly and Packaging as assigned, related to the manufacturing of drug product in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures. This position assists the Sr. Associate and Master Associate in performing assembly and packaging in designated functional manufacturing areas, supports troubleshooting of equipment, and aids in setup activities for automated and semi-automated machines.

Responsibilities

• Assists in the setup of automated autoinjector assembly machines, pre-filled syringe assembly machines, and semi-automated tabletop machines, including gathering tools, machine parts, and required documents.
• Retrieves components and equipment from storage.
• Assists with equipment changeover and minor equipment repairs or adjustments.
• Identifies and corrects problems in real-time, including mechanical and component issues.
• Performs all work in accordance with Company Policies and Procedures, documenting activities in controlled documents such as batch records, logbooks, or SOP attachments.
• Records all events in the batch record and escalates issues to the production supervisor.
• Assists with room cleaning in production areas, including sanitization, waste disposal, and rubbish transfer.
• Follows controlled documents to verify and document equipment calibration and usage.
• Completes logbooks as required.
• Performs assembly and packaging operations, including assisting with visual inspection and filling operations.
• Ensures components, materials, and supplies are stocked prior to operations.
• Moves product, components, and equipment within the assembly, packaging, and CNC areas.
• Communicates and hands off tasks to relief personnel during shift changes.
• Maintains production areas according to predefined 5S standards.
• Adheres to safety standards, identifies unsafe situations, and escalates appropriately.

Requirements

• Demonstrated ability to be organized and work well in small work groups.
• Strong mathematical skills, including addition, subtraction, multiplication, division, and conversions.
• Detail-oriented with the ability to read, comprehend, and follow written instructions.
• Strong written and verbal communication skills.
• Ability to work in a team environment.
• Experience in a related GMP environment within the biotechnology/pharmaceutical industry is strongly preferred.
• Ability to learn and perform basic computer operations, including MS Office, Outlook, and other computer-based software.
• High School diploma or GED plus a minimum of one (1) year of work experience in a GMP-regulated industry.
• Associate’s/Bachelor’s degree from an accredited institution or biotechnology vocational training is preferred.

Physical Demands

• Requires almost constant standing and walking.
• Works regularly under desirable conditions with some moderately disagreeable conditions in a manufacturing setting.
• Requires concentration, as errors might cause minor to moderate delays, confusion, or expense to correct.
• Involves some contact with other departments; must be able to discuss issues and ideas with an open mind and even temper.

Pay

The maximum pay rate for this position is $25 per hour.