QA Validation Engineer
2 weeks ago
GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client's needs. We have multiple projects that we support, and we are looking to add to our team, we are interested in talking to you if you fit the criteria outlined below:
Title: QA Validation EngineerThe QA Validation Engineer is responsible for the Coordination / direction and active participation in the validation and qualification of equipment, utilities, processes and software in compliance with clients policies, FDA, European cGMP and GAMP standards.
Major Duties and Responsibilities- Generation/maintenance/execution of Project Validation Plans and schedules.
- Generation of validation protocols and final reports to cGMP standards.
- QA support for validation investigations and implementation of corrective actions.
- Creation/Review/Approval of various validation and qualification documents.
- Management of validation, exception event, and change control processes.
- Documenting all activities in line with cGMP requirements.
- Performing cross training within the team and training of new team members.
- Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
- Coordinating activities to maximize the effectiveness of all of the team members.
- Communicating with peers and management regarding activities in the area, including elevation of events or concerns.
Essential Requirements
- Qualification and/or degree in engineering or scientific discipline.
- 2+ years plus validation/Quality experience in sterile/aseptic environment especially in the commissioning and qualification area.
- 2+ years plus of knowledge of cGMP and regulatory requirements relating to the pharmaceutical / medical device industry.
- Strong communication (written and oral), presentation and troubleshooting skill required.
- Effective interpersonal and organizational skills.
- Ability to work well both independently and in a team environment.
- Capable of prioritizing work and multitasking.
We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment. If you are a motivated Validation Engineer seeking an exciting challenge in the biopharmaceutical industry, we encourage you to apply.
To start the process click the Continue to Application or Login/Register to apply button below.
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