Primary and secondary packaging materials knowledge
Urs and fmea risk analysis expertise
The role focuses on leading process development for vials, packaging, and labeling solutions to ensure product performance and regulatory compliance throughout the product lifecycle
Job Summary
The role focuses on leading process development for vials, packaging, and labeling solutions to ensure product performance and regulatory compliance throughout the product lifecycle.
Candidates will be responsible for developing requirements specifications, conducting risk analyses, and planning technical tests including stability and transport studies.
The position offers an opportunity to work in a supportive team at Olink within Thermo Fisher Scientific, contributing to global health and safety through innovative protein biomarker discovery.
Matching Summary
The role focuses on leading process development for vials, packaging, and labeling solutions to ensure product performance and regulatory compliance throughout the product lifecycle.
Skills & Requirements
Must-have
3-5 years packaging development experience
Primary and secondary packaging materials knowledge
URS and FMEA risk analysis expertise
Stability and transport validation testing
Regulatory compliance ISO 13485 GMP FDA MDR
Root cause analysis and CAPA management
Nice-to-have
Lean Six Sigma continuous improvement methods
Strong analytical and quality-oriented mindset
Excellent Swedish and English communication skills
Proactive self-starter with team collaboration skills
Key Requirements
3-5 years experience in life science packaging development
Knowledge of plastic and glass vial materials
Experience with ISO 13485, GMP, FDA, and MDR regulations