Manufacturing Specialist I/II

Responsibilities

• New Product/Process Introduction and Changes — Facility Fit support
• New Product/Process Introduction and Changes — Manufacturing Record and procedure drafting
• New Product/Process Introduction and Changes — Equipment procurement or modification
• New Product/Process Introduction and Changes — Training generation
• Drafting, routing, and revision of manufacturing batch records, procedures, and supporting records
• Serve as technical subject matter expert in manufacturing operations, coaching manufacturing associates and supporting trainers in development of training records (TRNs)
• Manufacturing process support during on‑going shop floor execution
• Engage with Manufacturing Associates and Supervisors to understand barriers to success and identify opportunities for improvement
• Drive and manage projects with significant process improvement impact
• Lead implementations for corrective and preventive actions
• Partner with Compliance/QA for timely Deviation Investigation completion
• Support activities associated with Operational Excellence Initiatives including Error Proofing, Standardization, 5S, and Lean Manufacturing
• Support safety initiatives, compliance, and quality requirements

Requirements

• Demonstrated knowledge of downstream operations, cell culture, and/or fermentation
• Experience in single‑use platform technology (preferred)
• Bachelor’s degree in a related scientific or engineering discipline (preferred) with 1+ year’s related experience and/or training; or equivalent GMP manufacturing experience
• Requires minimal direction or supervision to execute against routine tasks
• Fluent in English with excellent written and verbal communication skills
• Detail‑oriented with good time management skills and customer focus
• Organized and able to focus in a fast‑paced, multi‑tasked environment while maintaining operational efficiency and a positive demeanor

Working Conditions

The job requires supporting a 24‑hour manufacturing facility which may include on‑call phone support or support overnight and on weekends.

The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations. Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene.

While performing the duties of this job the employee may use equipment and materials which include mechanical hazards, chemical hazards, electrical hazards, and tripping and falling hazards. The noise level in the manufacturing environment is moderate to high, however, the employee will routinely work in an office area.