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Subject Matter Expert
Eingestellt von Computer Futures - London & S.E(Permanent and Contract)
Gesuchte Skills: Engineering, Design
Projektbeschreibung
SUBJECT MATTER EXPERT
01/11/17 - 31/10/2018 SWITZERLAND SCHAFFHAUSEN
A thriving organisation in Schaffhausen, Switzerland are looking for a Subject Matter Expert. If you have a background in, scientific or engineering with demonstrable results to deliver new products or sustain existing products, then you could be the professional that we've been looking for.
WHAT WILL YOU BE DOING? As a Subject Matter Expert you will be - As required, design and develop secondary/tertiary packages for optimal equipment and process compatibility, considering patient/end user preferences and limitations.
* Provide technical input for primary packaging equipment, materials and packages to the PDMS team in order to assure compatibility between primary and secondary packaging processes.
* Design transfer/technology transfer/commercialization activities including process and equipment qualification (IQ/OQ/PQ).
* Collection of design transfer documentation for consideration within the Design History File
* Review and approve the following packaging documents: packaging component specifications, Packaging Bills Of Materials, Packaging component drawings, design history files (for combination products), Technical Design Requirements (TDR's), risk/criticality assessment and procedures for bulk and finished drug product.
. Authoring of Technical Development/Transfer Plans for Secondary/Tertiary Packaging project.
* Preparation and oversight of packaging development activities including preparation and organisation of transportation studies.
* Provide support to physical & cold chain shipping studies, line trial, packaging material qualifications, child resistant requirements, human factor studies and patient centric design.
* Achieve timely resolution of secondary packaging project related operational deficiencies, as required.
* Participates in risk remediation/reduction and drive toward root cause and robust corrective action/preventative action to improve process reliability.
WHAT SKILLS/EXPERIENCE SHOULD YOU HAVE?
- This position will require a minimum of a bachelor's degree in Engineering or related discipline or equivalent combination of education and work experience.
- Candidates shall have broad scientific or engineering expertise with demonstrable results to deliver new products or sustain existing products.
- Knowledge of packaging equipment is required.
- The ability to interpret engineering drawings is required.
- Secondary/Tertiary Material packaging experience is required, primary packaging material is a plus, package equipment qualification/validation knowledge is a plus.
STHREE ARE COMMITTED TO ENSURING EQUAL OPPORTUNITIES, FAIRNESS OF TREATMENT, DIGNITY, WORK-LIFE BALANCE AND THE ELIMINATION OF ALL FORMS OF DISCRIMINATION IN THE WORKPLACE FOR ALL STAFF AND JOB APPLICANTS. WE WELCOME APPLICATIONS FROM ALL SUITABLY QUALIFIED PERSONS, REGARDLESS OF THEIR RACE, SEX, DISABILITY, RELIGION/BELIEF, SEXUAL ORIENTATION OR AGE.
01/11/17 - 31/10/2018 SWITZERLAND SCHAFFHAUSEN
A thriving organisation in Schaffhausen, Switzerland are looking for a Subject Matter Expert. If you have a background in, scientific or engineering with demonstrable results to deliver new products or sustain existing products, then you could be the professional that we've been looking for.
WHAT WILL YOU BE DOING? As a Subject Matter Expert you will be - As required, design and develop secondary/tertiary packages for optimal equipment and process compatibility, considering patient/end user preferences and limitations.
* Provide technical input for primary packaging equipment, materials and packages to the PDMS team in order to assure compatibility between primary and secondary packaging processes.
* Design transfer/technology transfer/commercialization activities including process and equipment qualification (IQ/OQ/PQ).
* Collection of design transfer documentation for consideration within the Design History File
* Review and approve the following packaging documents: packaging component specifications, Packaging Bills Of Materials, Packaging component drawings, design history files (for combination products), Technical Design Requirements (TDR's), risk/criticality assessment and procedures for bulk and finished drug product.
. Authoring of Technical Development/Transfer Plans for Secondary/Tertiary Packaging project.
* Preparation and oversight of packaging development activities including preparation and organisation of transportation studies.
* Provide support to physical & cold chain shipping studies, line trial, packaging material qualifications, child resistant requirements, human factor studies and patient centric design.
* Achieve timely resolution of secondary packaging project related operational deficiencies, as required.
* Participates in risk remediation/reduction and drive toward root cause and robust corrective action/preventative action to improve process reliability.
WHAT SKILLS/EXPERIENCE SHOULD YOU HAVE?
- This position will require a minimum of a bachelor's degree in Engineering or related discipline or equivalent combination of education and work experience.
- Candidates shall have broad scientific or engineering expertise with demonstrable results to deliver new products or sustain existing products.
- Knowledge of packaging equipment is required.
- The ability to interpret engineering drawings is required.
- Secondary/Tertiary Material packaging experience is required, primary packaging material is a plus, package equipment qualification/validation knowledge is a plus.
STHREE ARE COMMITTED TO ENSURING EQUAL OPPORTUNITIES, FAIRNESS OF TREATMENT, DIGNITY, WORK-LIFE BALANCE AND THE ELIMINATION OF ALL FORMS OF DISCRIMINATION IN THE WORKPLACE FOR ALL STAFF AND JOB APPLICANTS. WE WELCOME APPLICATIONS FROM ALL SUITABLY QUALIFIED PERSONS, REGARDLESS OF THEIR RACE, SEX, DISABILITY, RELIGION/BELIEF, SEXUAL ORIENTATION OR AGE.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik