Manufacturing Technician I

Job Tittle: Manufacturing Technician I
Location: Norwood, MA
Duration: 6+ months (possible extension)

This position will be 1st shift, Monday through Friday.

Summary:
The individual in this role will be part of a cohesive team responsible for producing GMP mRNA-based medicines for evaluation in human clinical trials. He/she will support the handling and processing of materials within manufacturing operations at the Client Norward facility in accordance with established processes and procedures. The successful candidate will be able to document and communicate their operational observations clearly and efficiently.

Heres What Youll Do:

• Safely transport product, equipment, and materials (buffers, drug substance) from the warehouse to designated areas in accordance with Standard Operating Procedures (SOP) and EH&S requirements in support of the manufacture of mRNA medicines
• Assist manufacturing, QA and logistics colleagues manufacturing colleagues in other activities as required
• Strict adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
• Practice safe work habits and adhere to Client's safety procedures and guidelines.
• Complete documentation of activities in accordance with established procedures
• Immediate notification of production management of deviations to established processes or procedures
• Assist in the investigation of procedural deviations.
• Adhere to gowning procedures and maintain a clean general operating area.
• Adhere to documented waste handling procedures to respect environmental regulations.
• Product Products injury to him/herself and all adjacent work colleagues.
• Ability to lift and move products
• Receiving goods and materials through ERP management system, inspect and prioritize distribution of goods, materials, supplies and/or products ensuring accurate quantities and completing records.
• Handling material ensuring compliance throughout CNC space.
• Transport materials, supplies and/or products. Transfers materials to and from Logistics and Manufacturing. Ensure accurate quantities are delivered.
• Inventory Control: document all transactions/movements and perform physical inventory checks/reconciliations.
• Other responsibilities include proper storage, verification for accuracy, wipe down, maintaining required logs, records, security and safety.

Qualifications:

• High school diploma or GED required
• Experience in a highly regulated industry, Pharmaceutical, or related field
• At least 1-year regulated manufacturing or material handler a plus
• At least 1-5 years exp with SAP/ Oracle a plus
• Maintain Gown Certification
• GMP experience a plus. Good documentation practices are important.

Recommended Skills

• Buffers
• Clinical Trials
• Enterprise Resource Planning
• Good Manufacturing Practices
• Logistics Operations
• Management Systems