CQV Engineer

Job Overview

Responsible for providing direct services to site Technical Services management, aiding to increase the throughput of commissioning and qualification activities through the department and across the site.

* Will be expected to perform activities related to commissioning, qualification, requalification, validation independently.
* Please note that we will only be accepting applications from Candidates in possession of EU citizenship at this time. Please also note that there is no sponsorship for this position.
* This position will require availability to travel.

Tasks

* Commissioning, qualification, and requalification of new or existing manufacturing and laboratory equipment, facilities, services, and systems following regulatory guidelines such as GMPs or FDA.
* Qualification of computerized and automation systems.
* Writing of the corresponding qualification documents such as VP, IQ, OQ, PQ and PPQ protocols and reports, risk assessments, and development protocols.
* Providing support for the development of user requirements and functional specifications.
* Actively participating in all phases of validation projects in accordance with the client needed. Evaluating projects and providing technical information to others.
* Recommending to management as to the acceptance and release of qualified equipment/ facilities, services and/or systems.
* Supporting the generation and execution of all documentation related to demonstration batches, thermal studies, validation studies for equipment, engineering test runs, development studies.
* Reviewing technical and quality system documents such as SOPs, Change Control, Deviation Reports, and Batch Production Records, ensuring any document changes meet quality and validation requirements and are in full compliance with regulations, standards, and regulatory compliance issues.
* Providing technical assistance during investigations of process /equipment / cleaning / validation issues and aid in the resolution of validation deviations, protocol discrepancies and non-conformities.
* Providing effective solutions for the management of system deviations and non-conformities through the CAPA System.

Requirements

* Bachelor's degree in technical field (engineering, biology, chemistry, pharmacy).
* At least 3 years of experience in QA Oversight for C&Q activities, in Biopharma or Pharma industry.
* Generation and overview qualification documents like URS, System Risk Assessment, DQ, IQ, OQ, PQ, SOPs.
* Hands on commissioning, qualification and validation experience in the following disciplines is needed:
* Facilities (including clean rooms, HVAC)
* Utilities (including WFI / RO/ purified water, clean steam, clean air, compressed air and gases, process waste systems)
* Major qualification equipment
* Process and cleaning validation
* Equipment qualification
* Computer software validation
* Firm understanding of cGMP validation requirements / guidelines and familiarity with FDA regulatory requirements for the Pharmaceutical/biopharmaceutical industry.
* Proven capability to assess processes, equipment, and products for sources of variation, ability to analyze data and reach appropriate conclusions, and to perform and appropriately document deviations and investigations.
* Experience with Microsoft Office Suite.
* Fluency in English and German is a must.
* EU citizenship mandatory.