Quality Assurance CSV Engineer

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice, is searching for a Quality Assurance CSV Engineer to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work at Beerse office, until 31 December 2026.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

Scope of the role:

In this role you will assure that all CSV related regulatory requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase) for Car-T computerized systems. Review of trends within the CSV (including cGMP) area and initiation of actions/improvements. Act as a mediator between the various involved groups regarding CSV.

Main Job Tasks and Responsibilities:

• Act as Process owner for computer systems validation management (local applications).

• Maintain the Validation Master Plans up-to-date and ensure timely execution.

• Review and approve CSV documents such as SOPs, user requirements, impact/risks analysis’s, Validation Plans, tests, etc…) in order to maintain compliance to regulations, guidelines, Company policies and standards.

• Be part of IT / engineering teams and interact with other groups for the introduction of new systems and processes. To give advice and support for the preparation of CSV related activities and guard the cGMP aspects in new projects.

• Be a member of cross-functional teams to realize cross-departmental objectives.

• Be involved in Change Management.

• Address and follow-up of deviations occurred during execution of qualification/validation activities.

• Evaluate the incidents related to CS and propose corrective/preventive actions if necessary. Identify possible impact on the product quality and pass the incident to QA focus if this is the case.

• Provide periodic reports on quality system compliance (metrics).

• Prepare for system audits and inspections.

• Be the spokesperson for CSV related matters during audits and inspections.

• Follow-up activities related to CSV resulting from (internal and external) audits, quality system initiatives (FIR, CAPA, QIP,…), MAP, etc.

• Perform internal and supplier audits and guide auditee(s) to accomplish regulatory compliance.

• Be the CSV and Part11 expert within Car-T.

• Maintain a current knowledge of international regulations, guidelines and new evolutions related to CSV through courses, conferences, seminars, internal and external benchmarking and literature studies. Implement this knowledge to maintain and improve Computerized Systems Validation at Company Car-T.

• Prepare training material on regulatory CSV topics and train persons from Car-T organization.

• Stimulate innovative behaviour of the employees.

• Find and implement ways to keep knowledge and expertise in-house.

• Always respect our credo values.

Education and Experience:

• University/Bachelor’s Degree or Equivalent.

• Knowledge of cGMP’s: 21CFR11, 21CFR210, 21CFR211, Directives 75/319/EEC and 2003/94/EC Volume 4 and annex 11 and related GMP Guidelines and Preambles.

• Knowledge of GAMP’s: generic and specific (Global Information Systems, IT Infrastructure Control and Compliance, A Risk-Based Approach to Compliant Electronic Records and Signatures, Validation of Laboratory Computerized Systems, Testing of GXP System).

• Knowledge of SW development and testing processes.

• Knowledge of Quality auditing.

• Knowledge of Software quality metrics.

• Capacity to ‘translate’ technical information into information that can be understood at every level of the organization.

• Being able to correctly estimate the urgency, criticality and impact of decisions related to the function.

• Ability to multi-task and work on a variety of projects at one time.

• Ability to work independently and work in cross-functional team environment.

• Good communication skills.

• Good project management skills.

• Good problem solving skills.

• Fluent in English and Dutch (spoken and written).

• Specific know how of systems.

• Quality Management System.

• IT systems used within pharmaceutical and chemical manufacturing: PLCs, MES, LIMS, warehouse management systems, monitoring systems.

• Deviation and Change Management Systems. (e.g. IRIS, Comet).

• Document Management Systems (e.g. TruVault, Asset Management).

• Training Management Systems (e.g.Summit)

• Microsoft OS, networks, virus protection.

• Test Tools (e.g. qTest, KNEAT).

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Quality Assurance CSV Engineer, Quality Management System, CVS, CAPA, Validation Plan, CAR-T, GMP, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.

#LI-CM1 #LI-ONSITE #CONTRACT