Beschreibung
For a 1 year project with our client in Schaffhausen, we are looking ASAP for a Senior Subject Matter Expert.
PRINCIPAL RESPONSIBILITIES:
Lead or contribute to the following:
" Collaborate on Packaging and/or Technical Operations initiatives as required, based on business needs.
" 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 (TDRs), 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 organization 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.
COMPETENCY (knowledge, skills, abilities and experience required):
. 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
. Understanding of cGMP, Good Documentation Practices, and Regulations is required.
. The ability to lead and/or support multiple projects simultaneously is required.
. The ability to perform root cause investigations and write technical documents. In addition this position requires project management skills, as well as interpersonal communication skills.
. DEGREE: This position will require a minimum of a bachelors degree in Engineering or related discipline or equivalent combination of education and work experience. This position requires a minimum of 3 years of packaging engineering and/or design, or relevant experience is required.
. LANGUAGES: Fluent in written and spoken English. German is a plus. SPECIFIC SYSTEMS: Demonstrated experience in complying with one or more of the following is required: FDA CFR part 3, 4, 210, 211, and 820.