AI & Cloud Computer System Assurance (CSA) Engineer

Who we are Aizon is 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. - We’re 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. - We’re 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 company's 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 Aizon’s 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 Aizon’s 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, sit,e 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 don’t 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