CQV DSP


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

22nd August 2019

Location

Bern

Salary/Rate

Upto £100

Type

Contract

Start Date

01/09/2019

This job has now expired please search on the home page to find live IT Jobs.

CQV Engineer (all genders) Duration: 1 year with possibility for extensionLocation: Canton BernRemote: no / 100 % on site mandatory For one of my Greenfield clients I am currently looking for a CQV engineer. Main Responsibilities: The position holder acts as technical engineering specialist supporting construction, commissioning, verification and qualification activities for downstream equipment within the bulk process project.The position holder is responsible to ensure that the milestones for construction, commissioning, verification and qualification are met. The position holder is also responsible for the review and preparation of GxP relevant documents Technical Responsibilities: Construction Support (Field Engineering Support) Be the Engineering SME for the downstream processing area (Equipment & Overall Space) and support the construction team. Act as a link between, general planner and downstream equipment suppliers.Respond to Requests for Information (RFI) from and Contractors. If a RFI results in a Change, track and coordinate the actions accordinglyAttend the Walk downs for Construction and Mechanical CompletionSupport resolving issues that may arise in the field (clashes, etc.)CVQ & Automation Support Review, comment and approve the relevant CVQ and Automation Documentation within the given timelinesRespond to Requests for Information (RFI) from CVQ and Automation contractors. If a RFI results in a Change, track and coordinate the actions accordinglyPreparation of qualification documents (e.g. RTM, DQ, IQ, OQ, etc.)Attend equipment and software FATs as applicableAttend and support on-site CVQ activities to assure safe, compliant and timely executionSupervision of downstream processing equipment suppliers during CVQ phaseVendor Documentation Review, comment and approve the VTOPs and CTOPs for the downstream packages as per the instructions and workflows General activities Bears responsibility and accountability for working according to cGxP, health, safety and environmental requirements as laid out in the SOPs and procedures as well as all relevant external / governmental guidance.Support construction/ commissioning/qualification teams to ensure that the mechanical completion, commissioning and IQ/OQ/PQ steps are achieved in line with the integrate schedule and support the startup of the equipmentInvolvement in issue reporting, tracking and resolution and attending coordination meetings between the various disciplines to ensure smooth construction, commissioning, verification and qualification of the downstream processing equipmentSupports Lead DSP Equipment Engineering interfacing with others project stakeholders to assure overall coordination Supports the Maintenance Groups in the definition of the maintenance systems and maintenance schedule Education: Degree (Dipl. lng., Bachelor, Masters or higher) in life science, mechanical, process or chemical engineeringLanguages: English fluent in written and spoken, German and/or French are a plus. Experience: Min. 5 years of experiences in the life science, pharmaceutical or chemical industry as a project and/or C&Q engineerProven Experience and knowledge in biotech downstream processingSIP and CIP knowledgeExperience with Process Control Systems (e.g. Siemens)Understanding the needs for cGxP and CVQ Competencies: Technical expertise on biotech processes and hygienic designAble to work with the required oversight to fulfill deliverables within target dateApproachable Team player with good communication skillsProactive and solution orientedIndependent and exact workingReliable and in-time delivery of results If you are interested in this position please contact me on k.blomberg (at) realstaffing.com or give me a call on +41 (0) 44 588 2636. Looking forward to speaking to you. Regards Kaja Sthree Switzerland is acting as an Employment Business in relation to this vacancy.

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