Systems Engineering Consultant

We are looking for a Consultant (L2) - CSV to join our team remotely from the UK. This role is ideal for professionals with experience in validation and CSV projects who want to provide senior-level support to pharmaceutical clients, acting as a trusted consultant and technical reference., Provide senior-level support to pharmaceutical clients in CSV, validation, and potentially other GMP-related projects, ensuring compliance and delivering high-quality consultancy services., * Lead and execute CSV and validation activities (planning, risk assessments, IQ/OQ/PQ, reporting).

• Ensure compliance with GMP, GxP, and Data Integrity requirements.
• Act as the main client contact for validation topics.
• Review and approve validation documentation.
• Provide guidance and mentoring to junior consultants.
• Collaborate with client stakeholders in a consultancy environment.
• Manage project timelines and deliverables to meet client expectations., We are looking for: An enthusiastic and detailed orientated Computer System Validation (CSV) Specialist to support the technical administration of GMP informatics platforms and software for Hoddesdon Analytical and Process Chemistry laboratory employees. At Pharmaron we..., Validation Manager I am working exclusively with an expanding, multi-site European pharmaceutical business that has demonstrated exceptional growth over recent years. As part of this growth, the business has increased their operational delivery, as well as update equipment...

• 5+ years in validation and CSV projects in the pharmaceutical or regulated environment.
• Strong understanding of GMP, GxP, and regulatory expectations (EU GMP Annex 11, FDA 21 CFR Part 11, GAMP5).
• Consulting or client-facing experience is a strong plus.
• University degree in Life Sciences, Engineering, or similar.

Soft Skills

• Excellent communication and interpersonal skills.
• Proactive, structured, and solution-oriented mindset.
• Ability to work independently in remote project setups.
• Comfortable working in multidisciplinary, multicultural teams.

What You Bring

• Experience leading and participating in CSV projects across systems like ERPs, eDMS, eQMS, LIMS, SCADA, EBRs, and pharmacovigilance systems.
• Ability to assess system compliance with global regulatory standards.
• Fluent in English.

Why This Role is for You

• Excited to work with clients on critical projects from a remote location in the UK.
• Comfortable managing technical, regulatory, and client-facing responsibilities.
• Eager to learn and grow in a role exposing you to diverse systems and industries., Your in depth understanding of systems engineering across the systems engineering lifecycle and background in consultancy will help you to support my client's as a Senior or Principal Systems Engineering consultant. You will lead teams that use Systems thinking to analyse,...

• Competitive Compensation: Salary reflects your experience, plus additional benefits.
• Work-Life Balance: Remote work, flexible hours, shorter Fridays.
• Global Exposure: Multicultural team across multiple countries.
• Dynamic Environment: Young, enthusiastic team where your ideas are valued.
• Opportunities for Growth: Career development, leadership opportunities, and continuous learning.
• Drive Digital Transformation: Work on projects using the latest technologies to optimize quality processes.

For over 20 years, Rephine has helped leading Life Sciences companies improve manufacturing quality processes. Join us to grow your career and make an impact in a fast-evolving, global company.

At Rephine, we set the standard for quality assurance and GxP compliance in the Life Sciences industry. With offices in Barcelona, the UK, and China, we support Pharmaceutical, Biotech, and Medical Device supply chains globally., Our Sat Connect IC business unit, a division of our Satellite Systems business is a leading provider of ASICs, software, multi-beam electronically steered antennas, and complete systems for communication satellites, as well as ground and airborne..., Our Sat Connect IC business unit, a division of our Satellite Systems business is a leading provider of ASICs, software, multi-beam electronically steered antennas, and complete systems for communication satellites, as well as ground and airborne terminals. Apply (by...