Ai & Cloud Computer System Assurance (Csa) Engineer

buscojobs España; Barcelona; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading software-as-a-service provider focused on improving global health through optimized manufacturing processes seeks an AI & Cloud Computer System Assurance Engineer. This role is essential for ensuring regulatory compliance and involves direct oversight of quality assurance and computer system validation activities.

Servicios

Stock Options

Private Medical & Dental Insurance

Flexible schedule

Internal Training & Certifications

Professional development opportunities

Monthly Team Building Activities

Language Training Courses

Tech pack provided

Formación

• 2 years’ experience in biopharmaceutical regulated industry.
• Knowledge of CSA requirements and regulatory standards.
• Experience with cloud applications preferred.

Responsabilidades

• Oversee computer system validation for quality assurance.
• Support customer compliance tasks and audits.
• Help maintain regulatory readiness like GxP and 21 CFR Part 11.

Conocimientos

Communication

Problem-solving

Analytical skills

Negotiation

Leadership

Educación

Bachelor of Science in IT, Chemistry, Pharmacy, Biology, or related field

Descripción del empleo

AI & Cloud Computer System Assurance (CSA) Engineer

Barcelona

EUR 40.000 - 60.000

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

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

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 [e-mail]