Senior Manufacturing Specialist

About the role

Responsible for leading technical support activities for GMP Manufacturing Operations in a multi-product, large scale, biopharmaceutical facility. The role supports a 24‑hour manufacturing environment, may require on‑call phone support, overnight and weekend work, and involves working within a cGMP biotechnology facility with clean‑room operations (donning clean‑room attire, maintaining hygiene). Employees may encounter mechanical, chemical, electrical, and tripping/falling hazards; noise level is moderate to high, with routine office work.

Responsibilities

• New Product/Process Introduction and Changes including: Facility Fit support, Manufacturing Record and procedure drafting, Equipment procurement or modification, Training generation, Drafting, routing, and revision of manufacturing batch records, procedures, supporting records.
• Serve as technical SME in manufacturing operations, coaching and mentoring manufacturing associates, supporting trainers in development of TRNs.
• Manufacturing process support during ongoing shop floor execution.
• Engage with Manufacturing Associates and Supervisors to understand barriers to success, 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, Lean Manufacturing.
• Support safety initiatives, compliance & quality requirements.

Requirements

• Bachelor’s degree in a related scientific or engineering discipline preferred with 6+ years’ related experience and/or training; or equivalent experience.
• Requires minimal direction or supervision to execute against routine tasks.
• Fluent in English with excellent written and verbal communication skills required.
• Detail oriented, good time management skills, customer focused.
• Organized and able to focus in a fast‑paced, multi‑tasked environment while maintaining operational efficiency and positive demeanor.

Skills

• Demonstrated knowledge of downstream operations preferred.
• Experience with cell culture and/or fermentation preferred.
• Experience in single‑use platform technology preferred.