Job Title: QA Validation Engineer
We are seeking a highly skilled QA Validation Engineer to join our team at GerTEK, an engineering consultancy company specializing in project management, talent solutions, and commissioning qualification and validation services.
Responsibilities:
* Coordinate and direct the validation and qualification of equipment, utilities, processes, and software in compliance with client policies, FDA, European cGMP, and GAMP standards.
* Generate, maintain, and execute Project Validation Plans and schedules.
* Develop and review validation protocols and final reports to cGMP standards.
* Provide QA support for validation investigations and implement corrective actions.
* Manage validation, exception event, and change control processes.
* Document all activities in line with cGMP requirements.
* Perform cross-training within the team and train new team members.
* Participate in continuous improvement programs to implement improvements in manufacturing, quality, safety, and training systems.
* Coordinate activities to maximize the effectiveness of all team members.
Requirements:
* Qualification and/or degree in an engineering or scientific discipline.
* 2+ years of experience in validation/Quality in a sterile/aseptic environment, particularly in commissioning and qualification.
* Strong knowledge of cGMP and regulatory requirements in the pharmaceutical/medical device industry.
* Excellent communication, presentation, and troubleshooting skills.
* Effective interpersonal and organizational skills.
* Able to work independently and in a team environment.
* Capable of prioritizing work and multitasking.
What We Offer:
* Competitive compensation packages.
* Opportunities for professional growth in a dynamic and innovative work environment.