For our customer located in Stein/Switzerland we are currently looking for (m/f) a 6 Q&V Engineers to start as soon as possible for a project of 3-4 months duration.
- Type of placement: 4 months, external contract with possible long term extension
- Company: major Pharma company in Stein area
- Salary: level 2, please ask us for the exact rate range
(monthly all in salary levels in CHF, level1= 5-10k , level2=10-15k, level3= >15k)
Key Responsibilities and Deliverables
o Commissioning execution and approval. Includes vendor supervision on their testing scope and quality.
o Installation and Operational Qualification execution and approval. Includes vendor supervision on their testing scope and quality.
oCreation and approval of Commissioning and qualification reports.
o Support with resolving any deficiencies and deviations that may occur during commissioning and qualification.
o Update of User Requirement Specifications and other design documents to as-built state if required after commissioning & qualification.
o 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, e.g. 1 week in 4, for peak execution periods/critical path systems).
- 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.
o Background in either engineering or related scientific area
o Several years of experience in qualification / commissioning of lab equipment and/or manufacturing plants in GMP area
o Fluent German and English language written and verbal communication skills
o cGMP knowledge and knowledge of EMA and FDA predicate rules
o Able to work with minimum oversight fulfilling deliverables within target dates
• Preferred requirements:
o Experience with Commissioning / Qualification Approach.
Kindly be informed that this job offer is from our customer in Switzerland. Therefore we can only accept applications within the EU or applicants with Swiss work permissions.
Please attach your CV in Word format.
SimplyVision is looking forward to your application.