MCS Manufacturing Associate NS

We are seeking a Manufacturing Associate for the Night shift. In this role, you will be integral to supporting development, clinical, and launch activities within our cutting-edge manufacturing environment. Under general supervision, the Manufacturing Associate will perform operations as outlined in Standard Operating Procedures (SOPs) while adhering to Good Manufacturing Practices (GMP).

Key Responsibilities:

• Execute setup, cleaning, and sanitization of manufacturing equipment.
• Prepare buffers and media following detailed manufacturing procedures (MPs) and Standard Operating Procedures (SOPs).
• Perform in-process sampling, monitor critical processes, and troubleshoot basic equipment issues.
• Operate and maintain analytical equipment to support production activities.
• Perform washroom activities, including cleaning small- and large-scale production equipment.
• Work in a cleanroom environment, following gowning protocols and utilizing personal protective equipment (PPE).
• Maintain a clean, safe, and organized workspace aligned with safety and GMP standards.
• Initiate quality records and draft/revise documentation, including SOPs, MPs, and technical reports.
• Identify, recommend, and implement process improvements to enhance efficiency and compliance.
• Review and verify batch records, equipment logs, and other documentation for accuracy and compliance.
• Perform physically demanding tasks such as lifting (up to 35 lbs.), pushing/pulling (up to 50 lbs.), and standing for extended periods.
• Regularly perform bending, climbing, squatting, stooping, and reaching activities required on the production floor.
• Execute and monitor critical manufacturing processes, including validation protocols.
• Draft and revise SOPs, MPs, and routine technical documentation.
• Initiate and own quality records (e.g., CAPAs, CAPA-EV) and recommend process improvements.
• Train team members on hands-on tasks and GMP protocols as needed.
• Participate in safety initiatives and cross-functional teams to support manufacturing goals.
• Apply technical, scientific, and operational knowledge to troubleshoot and implement new technologies in production.

Preferred Skills

• Strong mechanical aptitude and experience troubleshooting machinery.
• Knowledge of GMP and regulatory requirements relevant to pharmaceutical manufacturing.
• Familiarity with analytical techniques and lab practices associated with biopharmaceutical production.
• Ability to engage in technical writing and documentation.
• Proficiency in using process control systems.
• Strong team player with the ability to communicate effectively with colleagues.
• Able to work in a fast-paced environment with shifting priorities.

Requirements

Basic Qualifications

• Bachelor’s degree OR
• Associate’s degree and 4 years of experience OR
• High school diploma/GED and 6 years of experience.

Preferred Qualifications:

• Background in Biological Sciences or Engineering.
• Prior experience in a regulated manufacturing environment.
• Understanding of purification processes and biomanufacturing.

Shift and Physical Requirements:

• Ability to work various shifts, including weekends, holidays, and rotating schedules (5x8 hrs, 4x10 hrs, or 3/4x12 hrs) based on production needs.
• Must be comfortable working in a cleanroom environment with steel toe shoes, full gowning, and gloves.
• Requires the physical ability to lift, push, pull, and perform repetitive tasks for extended periods.