Senior Computer System Validation (Compensation range: 75K )

About the Position: Our clients often hail us as the benchmark for excellence in Life Sciences product quality. We have cultivated expertise in global quality assurance and GxP compliance within the Pharmaceutical, Biotech, and Medical device manufacturing supply chains.

Are you passionate about the Pharma and Life Sciences field? Do you thrive in a team environment? Is continuous learning your driving force? Are you eager to lead Multi-Projects Consulting initiatives that make a real impact? Are you prepared to work within a globally distributed company?

We Offer:

• Competitive salary commensurate with experience, additional legal vacation days, and competitive benefits (between 40K and 60K).
• A highly qualified staff with extensive experience and a commitment to support your professional growth.
• Flexibility in the form of a hybrid work model, autonomy, shortened workdays on Fridays, and flexible working hours.
• A global company with a multicultural team.
• A comprehensive training and development program, including continuous training, English and Chinese language lessons, team-building events, social activities, and celebrations.
• An excellent work culture and environment within a young and enthusiastic team of consultants.

Your Responsibilities:

Our team of highly seasoned consultants executes critical projects for organizations worldwide, focusing on:

• GxP readiness: Assessing and enhancing product development and manufacturing quality while ensuring comprehensive compliance.
• Design review of new facilities, equipment commissioning, and qualification.
• Digital transformation: Advising on optimizing manufacturing quality processes through modern technology (e.g., cloud-based solutions, IoT, AI/machine learning), system validation, and data integrity assurance.
• Medical Devices: Navigating the latest regulatory requirements for smart/digital devices and health tracking applications.
• Quality Management System (QMS): Offering advisory services to implement systematic quality design, optimize business processes, and deploy the TrackWise Digital Quality Management Software.

Key Responsibilities:

Reporting directly to the CSV Area Manager.
Collaborating on GxP compliance projects, especially in Computerized Systems Validation.
Leading the validation of Computerized Systems projects, which includes customer service, project approach definition, overseeing validation activities, conducting follow-up meetings, drafting and reviewing validation documents, supporting test execution, and reporting.
Managing and planning resources internally for assigned projects.
Leading the consultant team for the assigned projects, collaborating, and supervising deliverables´ development and project activities´ execution.
Ensuring adherence to customer-agreed deadlines for deliverables and test execution.
Keeping clients and the Area Manager informed of project progress, incidents, and actions.

Your Team:

Our unwavering commitment to customers is what drives our continuous growth. Our consultants´ involvement, experience, and expertise are our most valuable assets. Join our energetic team of consultants, share our values and objectives, and grow with us. You can contribute to the success of our projects.

This Role Is Ideal for You If:

• You hold a bachelor´s degree in chemistry or engineering.
• You have experience working in the pharmaceutical sector and possess knowledge of pharmaceutical and chemical business operations, manufacturing, and quality processes (including GxP compliance, validation, and quality systems management, GMP Annex 11, 21CFR part 11, Data Integrity Principles, GAMP 5, and more).
• You bring expertise in computerized systems validation (ERP, eDMS, eQMS, LIMS, Laboratory systems, EBR-MES, SCADAs, etc.).
• You have experience in data integrity assessment and remediation projects.
• You´re well-versed in change or incident management related to computerized systems.
• Experience in IT infrastructure projects and Agile methodologies is a plus.
• You possess strong teamwork skills.
• You can effectively plan and manage multiple validation projects simultaneously in alignment with client requirements.
• You are available for travel.
• You have excellent communication skills, customer-oriented, can understand customer needs, translate them into technical solutions, and explain technical concepts to non-technical audiences.
• You are fluent in both Spanish and English, with other languages being a valuable asset.
• You´re eager to learn and motivated.
• You have access to a car.

Your Career:

We are a dynamic and ever-evolving organization, seeking professionals who wish to grow and advance their careers with us.