Manufacturing Specialist 1

About the role

Help build and sustain reliable, compliant manufacturing at a world-class, 24/7 biomanufacturing site. This role supports a round-the-clock operation and may require flexibility with working hours and shift rotation.

Responsibilities

• Blend hands-on support with strong documentation, planning, and problem-solving to keep production running smoothly and safely.
• Support operational readiness initiatives as well as site commissioning and qualification efforts.
• Coordinate batch planning, including process template creation, import, and management of preventive maintenance activities.
• Maintain accurate, current documentation; drive timely updates to records and implement redlines and process improvements.
• Career Development
  • Support troubleshooting, acting as a process subject matter expert for assigned area(s).
  • Coordinate non-batch activities, including changeovers, preventive maintenance, and column packing.
  • Avoid duplication
    • Assist with inventory management and support use of enterprise systems (e.g., SAP) for effective manufacturing operations.
  • Support technology transfer within the manufacturing domain.
  • Ensure compliance with procedures and safety requirements in the manufacturing environment.
  • Manage, perform, initiate, or support change management records, investigations, corrective and preventive actions, and continuous improvement activities.
  • Identify and drive improvement projects in drug substance manufacturing.
  • Assist and support internal and external inspections and audits to maintain compliance.

Requirements

• High School Diploma/GED and 10 years of related experience; OR Associate’s degree, preferably in life sciences or engineering, with 8 years of direct experience; OR Bachelor’s degree, preferably in life sciences or engineering, with 6 years of direct experience; OR Equivalent military experience/training.

Preferred Qualifications

• Strong current Good Manufacturing Practice (cGMP) manufacturing operations experience.
• Solid understanding of operations sequence and cadence of activities.
• Prior experience updating and creating manufacturing documents according to schedule.
• Training and certifications Preferred: BioWorks or BTEC Capstone cGMP coursework.

What helps you succeed here

• Strong verbal and written communication skills.
• Excellent time management and the ability to prioritize in a fast-paced environment.
• Adaptability—able to pivot and adjust plans as priorities shift.
• Critical thinking and superior problem-solving skills.
• A team-first mindset with the ability to work effectively in a global, cross-functional environment and build strong relationships.