Qualification Engineer

For our client in STEIN we are looking for a QUALIFICATION ENGINEER for a 4-MONTH contract.

JOB TITLE: QUALIFICATION ENGINEER

DURATION: 01/11/2018 TO 28/02/2019

LOCATION: STEIN

WORKLOAD: 100%

DESCRIPTION:

KEY RESPONSIBILITIES AND DELIVERABLES:

. Commissioning execution and approval. Includes vendor supervision on their testing scope and quality.
. Installation and Operational Qualification execution and approval. Includes vendor supervision on their testing scope and quality. 
. Creation and approval of Commissioning and qualification reports.
. Support with resolving any deficiencies and deviations that may occur during commissioning and qualification. 
. Update of User Requirement Specifications and other design documents to as-built state if required after commissioning & qualification. 
. Ongoing support for assigned systems, including follow-up with vendors if necessary until handover of systems to the User.
. The Commissioning & Qualification Engineering role (Upstream) is responsible for ensuring the milestone dates for commissioning and qualification of the assigned systems are achieved.
. Carry out shift work if required (intermittent, eg 1 week in 4, for peak execution periods/critical path systems).

PERFORMANCE EXPECTATIONS:

. Adherence to NVS/NEXT project procedures/requirements with respect to Health/Safety/Environmental, Quality (including GDP/GMP) and Commissioning and Qualification.
. Self-manage C&Q execution activities with respect to the relevant systems.
. Function as a key member of the C&Q Team, and provide guidance regarding the assigned systems.
. Liaise closely with the relevant vendors/providers/contractors, NVS representatives and SISK construction-phase representatives to ensure integration of activities and schedules with respect to the relevant systems.
. Maintain control over the activities and schedule with respect to the relevant systems.
. Participate in sessions to define/agree work breakdown structure with respect to the relevant systems.
. Report on key deliverable and dates and align with key milestones within the project's critical path.

Must haves: 

. Background in either engineering or related scientific area 
. Several years of experience in qualification/commissioning of lab equipment and/or manufacturing plants in GMP area 
. Fluent German and English language written and verbal communication skills 
. cGMP knowledge and knowledge of EMA and FDA predicate rules 
. Able to work with minimum oversight fulfilling deliverables within target dates

For further details please contact: Anna Undas.