Job title : Senior Engineer Equipment Qualification QCS
Prothya Job grade: 9
Reports to job title: Global Supervisor QCS
Unit & Department: Global Quality Control Support Department
Purpose of the job
The Senior Engineer – Equipment Qualification QCS is responsible for ensuring the integrity, reliability and compliance of analytical instruments and computerized systems throughout their lifecycle within Quality Control (QC) and Production environments. This role drives the qualification, calibration, maintenance, and retirement of equipment in alignment with global regulatory standards (GMP, GDP, FDA, EMA, ICH) and data integrity principles. Acting as a project leader and subject matter expert, the position ensures timely installation, validation, and integration of new systems, while maintaining operational continuity through strategic planning of re-qualification and preventive maintenance activities.
The Senior Engineer plays a critical role in safeguarding product quality and patient safety by implementing robust validation processes, managing compliance risks and leading continuous improvement initiatives. Additionally, the role supports digital transformation and automation projects, strengthens data integrity through risk assessments and remediation plans and provides expert guidance during audits and inspections. Through cross-functional collaboration with QC, Production, QA, IT and external suppliers, this position ensures efficient lifecycle management of equipment and systems, contributing to operational excellence and regulatory readiness across QC operations and Production.
Key activity
-
Project Leadership: Lead installation, qualification, and integration of new analytical instruments and computerized systems in QC laboratories and Production, ensuring timely delivery and compliance.
-
URS Development: Define and document User Requirement Specifications (URS) in collaboration with QC operations and Production, aligning with regulatory, business, and technical needs.
-
Regulatory Compliance: Ensure adherence to Data Integrity principles, 21 CFR Part 11, and Annex 11 requirements for computerized systems.
-
Commissioning & Documentation: Coordinate commissioning tasks, maintain traceability, and ensure full documentation for audits and inspections.
-
Qualification Protocols: Draft, review, and approve IQ/OQ/PQ protocols and reports in collaboration with QA and relevant stakeholders.
-
Acquisition & Progress Monitoring: Manage acquisition and qualification activities, track progress in MasterControl or equivalent systems, and escalate risks proactively.
-
SAP Ordering: Create purchase requisitions and manage ordering in SAP, ensuring timely procurement and budget compliance.
-
Technical Support: Provide expertise for validation of analytical and microbiological methods, including troubleshooting during qualification phases.
-
Process Optimization: Continuously improve qualification processes, SOPs, and templates to enhance efficiency and compliance.
2.Re-qualification, Calibration, and Maintenance :
-
Strategic Planning: Develop and implement annual plans for re-qualification and calibration, including resource allocation and vendor coordination.
-
Execution & Oversight: Prepare, execute and manage re-qualification and calibration activities for QC and Production instruments, ensuring minimal downtime.
-
Procedure Management: Update SOP’s and work instructions to reflect evolving best practices and regulatory changes.
-
Preventive Maintenance: Ensure timely preventive maintenance and repairs in collaboration with laboratories and external suppliers.
-
Maintenance Contract Management: Manage yearly maintenance contracts with suppliers, including negotiation, renewal, and compliance with SLA’s.
-
Supplier Relationship: Act as primary contact for suppliers regarding maintenance schedules, contract terms and performance monitoring.
3. Periodic Review of QC and Production Systems :
-
Compliance Monitoring: Prepare and maintain Periodic Review Reports for analytical instruments and computerized systems.
-
Audit Trail Review: Conduct periodic reviews of audit trails, user access, and system compliance to maintain robust data integrity.
4. Retirement Phase :
-
Decommissioning: Coordinate and document decommissioning and Out-of-Use activities for obsolete systems, ensuring proper data migration and compliance with retention policies.
5. QC Alarm Management:
-
Incident Investigation: Investigate QC alarm reports for controlled temperature areas, perform root cause analysis and assess impact on product quality.
-
Corrective Actions: Implement CAPAs and preventive measures to avoid recurrence.
6. Data Integrity Improvement Projects :
-
Risk Assessment: Perform detailed risk assessments to identify gaps in data integrity for analytical instruments and computerized systems.
-
Remediation Planning: Define and implement remediation actions to close identified gaps, ensuring compliance with global data integrity standards.
-
Cross-Functional Collaboration: Work closely with QC, Production QA, and IT teams to ensure timely execution of remediation plans.
-
Documentation & Reporting: Maintain clear records of risk assessments, remediation actions, and progress tracking for audits and inspections.
7. Continuous Improvement :
-
Identify and implement process improvements to enhance efficiency, reduce compliance risk, and optimize lifecycle management.
-
Drive digitalization initiatives and automation projects within QC and Production, leveraging emerging technologies for smarter workflows.
8. Subject Matter Expert (SME) :
-
Act as SME during internal audits, regulatory inspections, and customer audits.
-
Provide expert guidance on equipment qualification, computerized system validation and data integrity compliance.
-
Train QC and Production teams on validation principles and regulatory expectations.
Our Company
Prothya Biosolutions makes life-saving plasma medicines and is proud of that! Every day, Prothya colleagues take the extra mile to improve the health of millions of patients worldwide. Are you looking for a position at a flexible and fast-growing company with an exciting history? At Prothya you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn!
We offer
Prothya Biosolutions Belgium is part of an international biopharmaceutical group which offers long-term career perspectives and invests actively in on-the-job training.
In return for your performance, you shall receive a competitive salary, group and health insurance, meal vouchers, and eco-cheques, as well as a Flex Reward Plan. The Flex Reward Plan is a flexible compensation system through which employees can create a budget from their current salary components. Thanks to this plan, they can enjoy, on a voluntary basis and according to their personal choice, a series of benefits that Prothya Biosolutions Belgium offers once a year.
We also offer an attractive holiday system exceeding the legal holidays and homeworking after a successful onboarding (after 3 months).
Furthermore, we value mutual respect and diversity is our strength.
At Prothya, you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn!
Are you moving along? Then !
