Recipharm is hiring a Manager for the Computer System Validation (CSV), Commissioning & Qualification (C&Q) area!
Recipharm is a leading pharmaceutical company with over 75 years of experience providing integrated services, from drug development to manufacturing, always ensuring high standards of quality, safety, and regulatory compliance.
To strengthen our Engineering Department, we are looking for a Manager for the Computer System Validation (CSV), Commissioning & Qualification (C&Q).
The core mission is to manage the entire validation lifecycle, from user requirement specifications (URS) to final validation reports, ensuring that systems are safe, reliable, and produce consistent, tamper-proof electronic data.
This role bridges quality assurance, engineering, and IT to ensure data integrity and process safety.
Key responsibilities
- Computer System Validation (CSV), Commissioning & Qualification (C&Q) Leadership: Lead the full lifecycle for equipment and computerized systems, from initial User Requirement Specifications (URS) to final retirement.
- Protocol Management: Author and approve critical validation deliverables, including Validation Master Plans (VMP), Risk Assessments, and IQ/OQ/PQ protocols.
- Data Integrity Advocacy: Implement and verify controls for ALCOA+ principles, ensuring audit trails, e-signatures, and backup/restore procedures meet FDA 21 CFR Part 11 and EU Annex 11 requirements.
- Cross-Functional Collaboration: Act as the subject matter expert (SME) for internal and external audits, coordinating with Vendors, IT, and Production teams to resolve deviations and CAPAs. Perform change request impact assessment related with systems and equipments.
- Continuous Improvement: Drive the transition toward "digital validation" and paperless systems while maintaining a high state of inspection readiness.
Profile
- Education: Master degree in Engineering, Life Sciences, Computer Science, or a related technical field.
- Experience: 5+ years in a highly regulated GxP environment (Pharma/MedTech), with proven experience in both hardware qualification and software validation.
- Technical Expertise: Deep knowledge of GAMP 5, Risk-Based Validation, and the V-Model. Familiarity with systems like LIMS, PLC, or MES is a major plus.
- Soft Skills: Excellent technical writing skills and the ability to explain complex compliance requirements to non-technical stakeholders.
- Previous experience in coordination or leadership roles (preferred);
- Solid knowledge of GMP and Good Engineering Practices (GEP);
- Good IT skills and fluency in English;
What we offer
- Integration into a solid and growing international company;
• Integration into a specialized technical team focused on innovation and continuous improvement;
• Salary package aligned with the role and experience.
Location: Lisbon | Schedule: Full-time
If you are looking for a leadership challenge in a critical area for the quality and safety of medicines, we encourage you to apply.