Posted on Sep 30, 2020 by ITech Consult
Packaging Engineer- Engineering/ packaging development/ testing methodologies /English/ German
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Packaging Engineer
This position supports the establishment of a world class packaging development organization by providing technical support in the development, qualification and deployment of new packaging systems for pharmaceutical products.
The person in this position works under general direction of packaging project leads and the work is reviewed through consultation. The person in this position applies packaging engineering knowledge, principles and concepts to independently manage packaging development and qualification tasks within bigger projects.
Scope of this responsibility includes the support of development and qualification activities for global packaging solutions. Tasks in the areas of clinical packaging, product launches and marketed products can be assigned.
Tasks & Responsibilities:
. Support the development and qualification of global primary, secondary and tertiary packaging solutions for pharmaceutical products.
. Manage packaging development tasks within global teams. Drive the packaging topics to meet predefined timelines and the financial budget.
. Works autonomously on complex tasks or several parallel tasks and projects and fulfills deadlines. Project tasks are focused on execution and have some strategic relevance.
. Qualification of global packaging solutions in line with the current valid requirements
(eg Development of test protocols and reports, execute IQ, OQ, and PQ etc.).
. Support maintenance of global packaging solutions (eg maintaining global specifications, support change control records, provide impact assessments, execute requalification etc.).
. Ensure compliance with international regulations (GMP, SHE, pharmacopoeia's, authorities, requirements) and adherence to relevant Quality Directives, Procedures, Guidelines, GSP's/SOP's.
. Successful collaboration with internal and external stakeholders (Packaging Project Leads Device and Packaging Development teams, CMO, Portfolio Management PTDM, Procurement, QA, PTG sites, PTB sites, etc.).
. Provide packaging technical support to packaging project leads for global technical development teams (TDT), global product supply chain teams (PSCT), product technical teams (TPT), and clinical packaging teams, commercial product launches and post launch maintenance for global packaging solutions.
. Communicate effectively and in a timely manner. Regularly communicate task status, critical issues and events of the project to the packaging project leader, stakeholders and line function. Ensure that management is informed ahead of time when goals are not fully achieved.
. Bachelor degree, preferably with an engineering degree in packaging, packaging materials science, or a related field.
. +2 years of experience in primary, secondary and tertiary packaging development, or packaging for clinical/commercial drug products or combination products.
. Excellent collaborative and communication skills. Communicates clear and precise in a well-structured manner.
. Languages English essential, knowledge of German an asset
Nice to have:
. Statistical knowledge including DOE and QbD, statistical software such as Minitab.
. Knowledge of testing methodologies and test standards including, shock, drop and vibration testing, peel force testing, barrier analysis, CCI/Sterile integrity, DIN/ISO, USP, FDA, MHRA and ISTA/ASTM standards for packaging design and validation.
. Knowledge of packaging equipment, related packaging activities: eg bottles, blisters, labels, cartons, and printing systems.
. Knowledge on equipment IQ, OQ, and PQ and development of qualification protocols/reports for packaging and shipping qualification activities.
. Develop and maintain packaging specifications.
. Knowledge regarding design control, documentation, risk management and processes such as MRD, DIR, FMEA, Design Verification, and URS.
. Working knowledge of computer systems including TOPS, CAD or Solid Works, Google and Microsoft office tools including MS Project, and Adobe.
. Knowledge of industry best practices.
. Active and constructive contribution to the Packaging Team. Support team spirit, team alignment, share responsibility, share risks within the team beyond the function. Develop knowledge for the organization and share the gained know-how with the team members. Fosters team effectiveness towards a common goal.
. You have to be a teamplayer
. Structured working method
. Solution-oriented work
. Strong persuasive power
. Motivated to learn new process
. 07:00am - 12:00am and 01:00pm - 06:00pm
Reference No.: 919716SGR
Role: Packaging Engineer
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert.