Packaging Engineer (m/f/d)

Tasks & Responsibilities:

• Author technical documentation to support packaging development organization (e.g. requirements documents, risk assessments, protocol/reports)
• Act as project lead for packaging development projects protocol/reports)
• Manage timeline, budget and activities for the packaging project
• Communicate key risks/challenges to stakeholders as necessary
• Evaluate and develop new materials and/or alternate packaging materials, packaging solutions or packaging systems based on product, regulatory, business or technical requirements.
• Develop and qualify global primary and secondary packaging solutions
• Qualification of global packaging solutions in line with the current valid requirements (e.g. Development of test protocols and reports, execute IQ, OQ, and PQ etc.)
• Maintenance of global packaging solutions (e.g. maintain global specifications, support change control records, provide impact assessments, execute requalification etc.)

Must Haves:

• Bachelor degree, preferably with an engineering degree in packaging, materials science, or a related field
• Professional background: pharma or medical device industry for 3+ years
• 3 years of experience in medical device regulation and package engineering within the pharma industry
• Strong experience in budget planning, project timeline planning, problem solving
• Profound knowledge of ISO 9001 and ISO 13485
• Knowledge of ASTM D4169, ASTM D7386 and Container closure integrity testing
• Knowledge on equipment IQ, OQ, and PQ and development of qualification protocols / reports for packaging and shipping qualification activities
• First experience in project management within the pharma industry
• Hands on working experience in GMP environment and authoring technical documents
• IT skills: microsoft office, visio, timeline programs
• Fluent in English - written and spoken
• Confident presentation, networking, relationship building skills

Nice to Have:

• German or French
• CAD, Artios, palletization software