CSV Engineer (Regulated Life Sciences)

Be part of the Next Industrial Revolution - Behind every SaaS product is a Team

In Vimachem, we’re using technology to empower the people who manufacture medicines for our world. Since 2014, we have been developing the Vimachem Pharma Manufacturing Execution System (MES) leveraging the Industrial Internet of Things (IIoT), Cloud computing, and Artificial Intelligence (AI). Currently deployed in over 200 pharmaceutical sites globally, the Vimachem Pharma MES is enabling a healthier world by supporting pharmaceutical and biopharmaceutical manufacturers in bringing to market faster, affordable, and life-saving medications.

Today, we are going through one of the most exciting times for our company. We are growing rapidly globally and expanding our Quality & Compliance team, seeking a passionate and ambitious CSV Engineer to join our team. This role is perfect for someone driven to shape the future of digital compliance in Life Sciences, working hands-on with innovative technologies in a dynamic environment.

Our culture is fast-paced, entrepreneurial, and rewarding. We've been recognized as a "Great Place to Work" for multiple consecutive years by fostering an inclusive and mission-driven culture. If you are passionate about cutting-edge software, the future is bright for you at Vimachem, and we want to hear from you!

This position is a fully remote position for EU-based candidates.

About the Role

As a CSV Engineer, you will work closely with cross-functional teams, including implementation, engineering, and quality assurance, to deliver compliant, scalable, and robust systems that drive digital transformation for leading pharmaceutical and biotech companies around the world.

This position offers a unique opportunity to work at the intersection of technology, quality, and compliance, making a direct impact on the delivery of safer, more effective medicines to patients globally.

What will you do as a CSV Engineer?

• Leading and executing the validation lifecycle of GxP-regulated computerized systems (URS, FS/DS, Risk Assessment, IQ, OQ).
• Ensuring compliance with regulatory requirements such as 21 CFR Part 11, and EU Annex 11 and using GAMP 5 methodology.
• Reviewing and validating software used in manufacturing, laboratory, and clinical environments.
• Supporting the implementation and validation of electronic systems such as Electronic Batch Records (EBR) and Manufacturing Execution Systems (MES).
• Drafting and executing validation protocols and reports.
• Collaborating closely with cross-functional teams, including product, engineering, and client stakeholders.
• Providing training and guidance to project stakeholders on CSV methodology and compliance.
• Participating in the creation and continuous improvement of validation templates and tools.

The main qualifications for the CSV Engineer role are:

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field.
• Minimum 2 years of hands-on experience in Computerized Systems Validation in a regulated life sciences environment.
• Experience in a software vendor would be a plus.
• In-depth knowledge of GxP requirements, GAMP 5, 21 CFR Part 11, EU GMP Annex 11.
• Experience with validation of SaaS/Cloud-based solutions is a strong plus.
• Familiarity with risk-based validation approaches and ALCOA+ principles.
• Strong technical writing skills and attention to detail.
• Excellent English communication skills, both written and verbal.
• Self-starter with a proactive attitude.
• Ability to manage multiple projects and deadlines.

At Vimachem, we know that even exceptional candidates sometimes hesitate to apply. If you’re excited about this role but don’t meet every single requirement, we encourage you to apply - we’d love to explore your potential fit.

What’s in for You

Our team is a strong, diverse, hard-working team that values families, personal well-being, and meritocracy. We believe amazing results require amazing effort and commitment, and we perform bi-annual performance reviews and continuous feedback to ensure we reward our top performers.

Benefits of working with us include:

• Competitive salary and performance bonus.
• Employee Stock Option Plan (ESOP).
• Modern work environment with an open culture towards improvements and new ideas.
• Benefits package including Health insurance, Life insurance, Short-term Disability, and Long-term Disability.
• Continuous training, company workshops, and events.
• A buddy will support you with onboarding.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Help us build an inclusive community that will transform Life Sciences manufacturing.