Sr. Process Engineer; Aseptic Operation

Position: Sr. Process Engineer (Aseptic Operation)
* Own and govern asset information across the lifecycle, ensuring integrity, traceability, and alignment with ISO 55000 Asset Information Management requirements, including URS, FS/DS, P&IDs, equipment files, and SAP CMMS records.
* Lead asset criticality assessments and risk-based prioritization using failure modes, risk priority numbers (RPNs), and business impact analysis to support maintenance and investment decisions.
* Ensure alignment between asset performance objectives, site asset management plans, and production demand.
* Ensure engineering activities comply with GMP, EHS, and ISO 55000/55001 requirements.
* Author, review, and approve SOPs/, change controls, deviations, and CAPAs.
* Lead and support qualification and validation activities (IQ/OQ/PQ), ensuring engineering documentation supports regulatory inspections and audits.
* Act as a subject matter expert during internal and external audits related to equipment, asset management, and reliability.
** 7.
** Completes any other duties/responsibilities assigned by senior management
** 5+ years
** of engineering experience in aseptic fill/finish biotech or pharmaceutical manufacturing.
** 4+ years
** of experience with isolator, Vial Washer, Dehydrogenation Tunnel, Isolator, Capper.
* Experience in Aseptic processing expertise
* Technical problem-solving and root cause analysis
* Knowledge of Six Sigma/Lean principles is a plus.
* Strong knowledge of sterile filling operations, aseptic techniques, and contamination control.
* Proven ability to successfully lead projects from start to finish, ensuring they are completed on time, within budget, and meet high standards of quality.
* Proven experience supporting cGMP environments and regulatory inspections.
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