AI & Cloud Computer System Assurance (CSA) Engineer
AI & Cloud Computer System Assurance (CSA) Engineer
Posted on :
02-06-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Who we are
Aizonis a software-as-a-service provider that transforms manufacturing operations in life science industries using advanced analytics and artificial intelligence.
Following our recent Series C round of growth funding we are looking for ambitious new team members motivated to directly impact our future growth and success as we launch what we consider Aizon 3.0. Aizon is helping pharma manufacturers and CDMOs make better decisions in GMP operations.
- What makes us different from other manufacturing platforms We help operations leaders and engineers avoid endless cycles of chasing data in disparate and heavy-handed systems and rapidly understand how to run their manufacturing processes better.
- Were solving multiple problems in GMP operations that cost manufacturers millions yearly while accelerating their digital maturity journey. One of our unique capabilities is the ability to operationalize the use of predictive AI models in real-time without a big data science staff.
- Were backed by both industry and software investor firms like NewVale Capital Atlantic Bridge Danaher Honeywell CrossLink and UnCork with solid industry and technology expertise.
Our mission is to improve global health by optimizing how medicines are manufactured so that pharma and biotech companies can provide patients worldwide with the right medicine at the right time and price.
Join us if you are motivated to directly impact our companys success and growth path forward and more importantly by positively contributing to the life science industry and deserving patients worldwide.
THE POSITION
The GxP Compliance area is essential in ensuring regulatory compliance across Aizons core platforms including the Aizon Cloud Platform Aizon Execute Platform and VaaS Platform. This role is responsible for maintaining the Aizon AI Platform in a state of readiness for applicable regulations such as GxP and 21 CFR Part 11 ensuring it consistently meets current regulatory requirements and expectations.
The position involves providing oversight on regulatory compliance matters including internal processes and computer system validation activities helping to maintain a validated state of control. It also supports tasks related to customer and partner compliance and contributes to marketing initiatives from a compliance perspective.
Reporting directly to the Chief Scientific Officer (CSO) this role also serves as the Deputy to the Quality Assurance
Responsibilities
- Provide direct oversight for computer system validation from a quality assurance perspective to ensure quality and compliance requirements are met
- Provide guidance on Computer System Assurance (CSA) validation issues and discrepancies
- Support investigation of CSA defects and quality records (deviation corrective actions)
- Review CSA validation activities including deliverables from a regulatory compliance standpoint
- Provide support to external and internal audits related to computerized system validation activities
- Advise a cross-functional team in an efficient manner including but not limited to excellent communication and time management skills to share responsibilities and expectations and accomplish goals throughout timelines
- Help establish and sustain Aizons computer system validation global policies and standards that incorporate industry best practices and are health authority compliant
- Partnering with internal and external teams sharing information to increase the collective understanding of QA and Compliance programs
- Ensuring alignment of processes procedures and methods across multiple organizations (internal and external)
- Ensuring systems are fully implemented and integrated with other quality management systems site and global functions
- Authoring and /or revising SOPs
- Ability to provide guidance on revising validation documents and protocols
- Administer applicable electronic systems
- Interacts with senior internal personnel and external partners on significant matters often requiring coordination across facility locations
- Contribute to projects related to CSA improvements
- Support the Compliance team on computerized system audits to ensure compliant vendor/supplier management programs and services.
- Support to customer and partner activities based on compliance services
- Support to Marketing and Pre-Sales activities
Knowledge and experience
- Bachelor of Science in IT Chemistry Pharmacy Biology or related science or technical field
- At least 2 years experience in the biopharmaceutical regulated industry (FDA EMA) with experience in either Quality Assurance Quality Management IT Compliance or equivalent
- Demonstrate proficiency and thorough knowledge of computer system assurance (CSA) requirements defined by applicable authorities and/or industry groups
- Thorough knowledge of quality management and CSA (GMP 21 CFR Part 11 Annex 11 Data Integrity GAMP) aspects of computer system applications
- Knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11 Part 820 Annex 11 GAMP5
- Good knowledge of regulatory requirements (FDA EMEA ICH)
- Knowledge about cloud applications should be required and AWS is desirable
- Experience in working on SaaS System Validation is desirable
- Experience in international and multidisciplinary environments.
- Operational knowledge and experience with IT systems and applications in a GxP environment
- Proficient in spoken and written English
Skills
- Capable of working with a dynamic product that is ever-changing and evolving rapidly
- Excellent communication and negotiation (written verbal and presentation) skills and advanced problem-solving orientation and decision-making skills
- Strong analytical and creative problem-solving skills
- Ability to take smart risks and champion new ideas
- Team player collaborative innovative and get things done mind
- Ability to understand business requirements and translate them into technical requirements
- Show initiative in setting and meeting goals within an environment of managed change
- Ability to work under pressure responsible for multiple important tasks in parallel
- You take ownership and feel responsible for the product as a whole
- You dont mind getting your hands dirty
- Commitment to quality
- You take responsibility for the success of the project
- Ability to evaluate risks define and execute action plans and propose innovative solutions to solve problems
- Ability to work on multiple projects concurrently and prioritize resources
- Strong ability to motivate people and to negotiate win-win solutions in a matrix-oriented organization
- Strong interpersonal and leadership skills
- Proven ability to develop present and justify positions to all levels within the company
- Demonstrates attention to detail and organizational skills
- Results-driven with a strong customer and quality focus
- Technical skills based on cloud platforms and easiness to learn technological cloud and AI concepts
What We Offer
Unique opportunity to join our company as it scales with great market traction and huge potential to continue growing
Competitive salary in the sector and scheduled performance/salary reviews
Stock Options
Private Medical & Dental Insurance
Internal Training & Certifications
Professional development and collaborative environment
Flexible schedule & Intensive Fridays
Flexible Remuneration Options
Language Training Courses
Top-notch tech pack We are Mac lovers!
Monthly Team Building Activities
We are committed to providing an inclusive environment where all employees feel mutual respect and are contributing to the good of society. We are a group of creators with diverse backgrounds (over 27 different citizenships in our company) and are proud to be an equal opportunity workplace. All employment is decided based on qualifications merit and business needs. If you need assistance or accommodation due to a disability you may contact us at
Employment Type
Full-Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
