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 NPIs 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 (PreSterilization 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.
• 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 152231.
• Establish and validate label data flows (UDI LOT/EXP) barcode systems print verification eIFU (where permitted) and translation/artwork processes.
• Manage label control procedures UDI assignment system IQ/OQ/PQ and changecontrol documentation.

C. Sterile Packaging (SBS Design & Validation)

• Lead sterile barrier system validation according to ISO 116072.
• 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 10⁶.
• Maintain sterilization validation plans PQ documentation release criteria requalification cycles and supplier oversight.
• Manage EO (ISO 11135) radiation (ISO 111371:2025) and VH₂O₂ (ISO 22441) modalities including requalification and residuals per ISO 109937.
• 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.