Subject Matter Expert

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 (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 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, Primary packaging material is a plus, package equipment qualification/validation knowledge is a plus.
. Understanding of cGMP, Good Documentation Practices, and Regulations is required.
. Knowledge of temperature control/cold chain distribution and its application to pharma & medical device products is preferred.
. 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 bachelor's degree in Engineering or related discipline or equivalent combination of education and work experience. Candidates who possess a degree in Mechanical, Biomechanical or Materials Engineering are preferred. Candidates who possess a process excellence certification are also preferred. 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.
. Also ICH and industry technical standards relative to Combination Product development are a plus. Experience with FDA regulated Design Control, Change Control, CAPA, and ISO 13485, The ability to use statistic techniques when analysing data and make rational and logical decision based on that analysis.

PHYSICAL REQUIREMENTS/WORKING CONDITIONS:

Works in an international environment across different time zones