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Device Packaging Project Leader
Eingestellt von RM IT Professional Resources AG
Gesuchte Skills: Design, Engineering
Projektbeschreibung
Packaging & Device Project Leader with profound understanding of product processes and applied statistics wanted for our Basel based client in the pharmaceutical sector.
YOUR EXPERIENCE/SKILLS:
- PhD, Dipl. Ing. in Mechanical Engineering or Pharmaceutical Technology
- 5+ years professional experience in Pharmaceutical Manufacturing (preferably assembly & packaging)/Manufacturing Science and Technology/technical Development projects
- Understanding of product processes along with strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities
- Fundamental understanding of standard device/packaging analytical testing
- Expertise in reviewing and writing technical reports as well as a proven track record of successfully applied project management skills
- Proficiency in design control, documentation, risk management and processes such as DMR (Device Master Record), DHF (Design History File), pFMEA, Design Verification, and URS (User Requirement Specifications) along with knowledge of 21 CFR part 210/211, 21 CFR part 4/820 and ISO 13485, ISTA, ASTM and EMA medical device directive
- Languages: fluent English both written and spoken, additional knowledge of the German language is considered an advantage
YOUR TASKS:
- Providing technical expertise from commercial point of view during device development stages and process commercialization
- Supporting Launch Site Decisions at such as PAC (Post Approval Commitment) by providing analysis of technology, capacity, and skills by performing inter-functional evaluations as well as making recommendation to PAC for assembly & packaging site selection
- Defining and monitoring project scope and timing as well as assuring that all activities are performed according to current processes and standards (GMP, HSE, Regulatory)
- Acting as a manufacturing representative during device development stages (design control) and in the packaging design process for the BTDM product portfolio
- Functioning as a manufacturing representative and supporting Site Engineering in defining assembly & packaging equipment design/qualification related to transfer/launch products.
START: ASAP
DURATION: 06MM+
LOCATION: Basel, Switzerland
REF.NR.: BH10808
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
DUE TO WORK PERMIT RESTRICTIONS WE CAN UNFORTUNATELY ONLY CONSIDER APPLICATIONS FROM EU OR SWISS CITIZENS AS WELL AS CURRENT WORK-PERMIT HOLDERS FOR SWITZERLAND.
GOING THE EXTRA MILE
NEW TO SWITZERLAND? In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
Work permit and much more
YOUR EXPERIENCE/SKILLS:
- PhD, Dipl. Ing. in Mechanical Engineering or Pharmaceutical Technology
- 5+ years professional experience in Pharmaceutical Manufacturing (preferably assembly & packaging)/Manufacturing Science and Technology/technical Development projects
- Understanding of product processes along with strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities
- Fundamental understanding of standard device/packaging analytical testing
- Expertise in reviewing and writing technical reports as well as a proven track record of successfully applied project management skills
- Proficiency in design control, documentation, risk management and processes such as DMR (Device Master Record), DHF (Design History File), pFMEA, Design Verification, and URS (User Requirement Specifications) along with knowledge of 21 CFR part 210/211, 21 CFR part 4/820 and ISO 13485, ISTA, ASTM and EMA medical device directive
- Languages: fluent English both written and spoken, additional knowledge of the German language is considered an advantage
YOUR TASKS:
- Providing technical expertise from commercial point of view during device development stages and process commercialization
- Supporting Launch Site Decisions at such as PAC (Post Approval Commitment) by providing analysis of technology, capacity, and skills by performing inter-functional evaluations as well as making recommendation to PAC for assembly & packaging site selection
- Defining and monitoring project scope and timing as well as assuring that all activities are performed according to current processes and standards (GMP, HSE, Regulatory)
- Acting as a manufacturing representative during device development stages (design control) and in the packaging design process for the BTDM product portfolio
- Functioning as a manufacturing representative and supporting Site Engineering in defining assembly & packaging equipment design/qualification related to transfer/launch products.
START: ASAP
DURATION: 06MM+
LOCATION: Basel, Switzerland
REF.NR.: BH10808
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
DUE TO WORK PERMIT RESTRICTIONS WE CAN UNFORTUNATELY ONLY CONSIDER APPLICATIONS FROM EU OR SWISS CITIZENS AS WELL AS CURRENT WORK-PERMIT HOLDERS FOR SWITZERLAND.
GOING THE EXTRA MILE
NEW TO SWITZERLAND? In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
Work permit and much more
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik