Staff Engineer (Cleaning, Labeling, Packaging & Sterilization)

Position Summary

The Cleaning, Labeling, Packaging & Sterilization staff Role is an exciting opportunity to become a SMEs and to be the Point of Contact for the (XXXX) Site. The role will have contacts across a global network and will ensure that the processes can be validated and optimized while supporting NPI’s from other locations. The SME Role includes:

• Ownership and development of the Cleaning, Labeling, Packaging & Sterilization Technical Competency and Technology Roadmap for the XXXX site.
• Identifying and introducing new technologies and processes that enable product roadmap and improve cost and time to market (CTM and TTM).
• Serve as the subject matter expert (SME) in Cleaning, Labeling, Packaging & Sterilization.
• Develop, maintain, and improve CPLS standards, procedures, and work instructions.
• Pioneering incremental and step change continuous improvement initiatives, that facilitate NPI to be faster, future-fit and differentiated.
• Aligns with the business on digital programs and drives relevant initiatives within TECS.

Technical Responsibilities (Short Business Version)

A. Cleaning (Pre‑Sterilization Manufacturing Cleaning)

• Define and validate cleaning processes (IQ/OQ/PQ), including residue, endotoxin, and bioburden limits in line with ISO 19227, ISO 11737, and ISO 10993‑18.
• Specify and qualify cleaning chemistries, equipment, and cleanliness acceptance criteria.
• Lead risk management activities (ISO 14971), including CAPA and audit support.
• Ensure appropriate cleanroom classification and controls per ISO 14644.
• Maintain cleaning validation documentation, trend analyses, and risk files.

B. Labeling

• Ensure compliance with FDA 21 CFR 801, EU MDR Annex I (Section 23), and ISO 15223‑1.
• Establish and validate label data flows (UDI, LOT/EXP), barcode systems, print verification, e‑IFU (where permitted), and translation/artwork processes.
• Manage label control procedures, UDI assignment, system IQ/OQ/PQ, and change‑control documentation.

C. Sterile Packaging (SBS Design & Validation)

• Lead sterile barrier system validation according to ISO 11607‑2.
• Define and execute integrity and performance testing (ASTM F88, F1929, F2096).
• Select and justify packaging materials (e.g., Tyvek, films, trays), including microbial barrier rationale, aging, and distribution claims.
• Oversee IQ/OQ/PQ of sealing and thermoforming processes.

D. Sterilization (Modality Selection, Validation & Control)

• Own the definition, validation, and routine control of sterilization processes to SAL 10⁻⁶.
• Maintain sterilization validation plans, PQ documentation, release criteria, requalification cycles, and supplier oversight.
• Manage EO (ISO 11135), radiation (ISO 11137‑1:2025), and VH₂O₂ (ISO 22441) modalities, including requalification and residuals per ISO 10993‑7.
• Lead supporting microbiology activities (ISO 11737) and ensure cleanroom readiness (ISO 14644).

Minimum Qualifications (Required):

• B.S in Mechanical Engineering or related discipline with 4+ years of experience in at least 2 of the 4 processes.
• Excellent command of written and spoken English
• Experience with quality management systems (ISO 9001, AS9100, ISO/IEC 17025).
• Excellent analytical, organizational, and communication skills.
• Proficient in Microsoft Office tools
• Familiarity with statistical process control (SPC) and measurement system analysis (MSA).
• Experience with automation and digitalization
• Proven track record overseeing the introduction of new technology from early identification through the release of an application for serial manufacturing.
• Lean 6 Sigma qualification such as Green Belt would be benefitial.