Packaging Engineer (f/m/d) - pharma or medical device industry/ GMP / project management / ISO 9001 and ISO 13485 / ASTM D4169, ASTM D7386 / IQ, OQ, and PQ / English
Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly Packaging Engineer.
Packaging Engineer (f/m/d) - pharma or medical device industry/ GMP / project management / ISO 9001 and ISO 13485 / ASTM D4169, ASTM D7386 / IQ, OQ, and PQ / English
Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly Packaging Engineer.
Background:
This position will be with the Packaging Engineering Parenterals (MMDEDP) department at Roche. We are looking for a candidate with a minimum of 3 years of experience in pharmaceutical devices and packaging. This role will have a heavy focus on technical writing and documentation including writing protocols and test results. As a support to internal Roche engineers we are looking for organized and motivated individuals looking to progress in their career. Additionally, we are seeking individuals who are ready to lead projects and take the drive themselves. Please note, that this position focuses more on technical writing and project management for primary and secondary packaging.
The perfect candidate: The perfect candidate has a degree in engineering or packaging and at least 3 years of relevant experience within a GMP regulated working environment. The candidate should have a pharmaceutical background with a strong knowledge of medical device regulations. Additionally, first hands-on experience in project management is a must have qualification.
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
•First experience in project management 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
• 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 Haves:
• German or french
• CAD, Artios, palletization software
Reference Nr.: 922664SDA
Role: Packaging Engineer
Industrie: Pharma
Workplace: Basel
Pensum: 100%
Start: 01.07.2023
Duration: 12++
Deadline: 04.06.2023
If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.
About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.