Senior Principal Aseptic Filling Systems Engineer

6014-Janssen Biotech, Inc. Legal Entity

Wilson (NC)

On-site

USD 140,000 - 190,000

Full time

6 days ago

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Job summary

Johnson & Johnson is seeking a Sr. Principal Process Engineer – DP Aseptic Biotherapeutic Filling Equipment in Wilson, NC.

You will lead end‑to‑end process engineering for the design, implementation, and start‑up of state‑of‑the‑art aseptic filling systems for vials and prefilled syringes in a new cGMP facility. You will guide technology choices, coordinate with cross‑functional teams and external vendors, and ensure compliance with global regulatory standards while driving project momentum and

Qualifications

Bachelor's Degree in engineering is required.
Minimum 10 years of process engineering/capital projects for aseptic filling systems in a cGMP environment.
Experience as a technical lead/SME for aseptic filling of sterile biologics.
Experience with design, installation, commissioning, C&Q and start-up of filling lines; knowledge of FDA cGMPs and EU Annex 1.
Located on-site in Wilson, NC; strong cross-functional leadership in matrixed settings.

Responsibilities

Lead development and delivery of aseptic filling line documentation (URS, data sheets, specs, P&IDs, PFDs).
Select equipment vendors; manage performance through project execution.
Design and engineer aseptic filling line equipment with suppliers and stakeholders.
Own layout/integration of filling line within facility; ensure compliance with Annex 1.
Lead FAT, SAT, C&Q and start-up activities for filling systems.
Drive issue resolution during C&Q/start-up to achieve qualification readiness.