Packaging Engineer I

Tranzeal Inc.

10 months ago

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Job Responsibilities:

Develop and qualify global primary and secondary packaging solutions for sterile, non-sterile and combination products, incl. author/co-author the related packaging specifications and qualification documentation
Qualification of global packaging solutions in line with the current validation requirements (e.g. Development of test protocols and reports, risk assessment, execute IQ/OQ/PQ, and shipping qualification)
Maintenance of global packaging solutions (e.g. support change control records, provide impact assessments, execute requalification)
Evaluate and develop new materials and/or alternate packaging materials, packaging solutions or packaging systems based on product, regulatory, business or technical requirements
Support or lead projects delivering innovative packaging technologies and systems under Roche global packaging technology centers

Education & Qualifications:
Personal Requirements:

Bachelor degree, preferably with an engineering degree in packaging, materials science, or a related field
At least 1 year working experience in relevant field
Proficient technical leadership, collaboration and communication skills
English language proficiency required

Technical Requirements:

Knowledge of packaging testing methodologies and standards including, shock, drop and vibration testing, peel force and tensile testing, barrier analysis, CCI/Sterile integrity, DIN, ISO, ISTA, USP, FDA, MHRA and ASTM standards for packaging design and validation
Knowledge of packaging process equipment, related to steriles, and non-steriles, and combination products packaging activities (e.g. vials, PFS, devices, aseptic form/fill/seal, blister and bottle filling lines), printing systems and serialization
Knowledge on equipment IQ, OQ, and PQ and development of qualification protocols / reports for packaging and shipping qualification activities
Knowledge of design control for combination products
Working knowledge of computer systems including TOPS, CAD or Solidworks, and Microsoft tools including MS project, and Adobe
Knowledge of industry best practices and technical writing skills such as GMP and GDP

Packaging Engineer I · Tranzeal Inc.