Job description
Position Overview:
We are seeking a detail-oriented and proactive Project Engineer – Compliance & Validation to support the development, validation, and continuous improvement of (bio)analytical methods and quality control processes within our pharmaceutical production and laboratory operations. This part-time role focuses on ensuring compliance with international regulatory standards, driving method validation and transfer initiatives, and supporting quality assurance across the product lifecycle.
The ideal candidate will have a strong technical background in analytical testing, experience in pharmaceutical quality systems, and a passion for continuous improvement and compliance excellence.
Key Responsibilities:
* Compendial Compliance & Monitoring:
Regularly monitor updates from pharmacopeial and regulatory bodies (e.g., USP, EP, JP) and assess their impact on existing (bio)analytical methods and QC procedures.
* Method Validation & Transfer:
Lead and coordinate the validation, transfer, and implementation of (bio)analytical methods across laboratories, ensuring robustness, accuracy, and regulatory compliance.
* Project Management:
Plan, execute, and communicate project timelines, deliverables, and risks to stakeholders. Manage budgets, resources, and cross-functional collaboration for QC-related projects.
* Documentation & Compliance:
Draft, review, and maintain critical quality documents in line with GxP and internal quality standards, including:
o Method validation protocols and reports
o Change control requests
o SOPs and technical rationales
o Risk assessments and risk registers
* Laboratory Support & Implementation:
Develop and implement validation and transfer strategies; coordinate practical execution by trained laboratory analysts; evaluate data and draw evidence-based conclusions.
* Problem Solving & Continuous Improvement:
Act as a key problem solver during deviations, out-of-specification (OOS) results, or process failures. Apply structured methodologies such as DMAIC for root cause analysis and corrective actions.
* Audit & Inspection Readiness:
Provide technical support during internal audits, regulatory inspections, and supplier assessments.
* Supplier & Contract Lab Coordination:
Liaise with external laboratories and vendors to ensure timely delivery of testing services, method validation support, and compliance alignment.
* Innovation & Technology Adoption:
Support the implementation and training of new test methods, technologies, and process analytical tools (e.g., PAT – Process Analytical Testing).
Qualifications & Requirements:
* Bachelor’s or Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
* Between 1 to 3 years of experience in pharmaceutical quality control, method validation, or regulatory compliance.
* Proven experience with analytical techniques such as HPLC, UPLC, GC, ELISA, SDS-PAGE, IEF, Karl Fischer, TOC, AAS, ICP-OES, and Western Blot.
* Strong understanding of GMP, GLP, and regulatory requirements (e.g., FDA, EMA).
* Experience with change control, risk management (e.g., FMEA), and documentation systems.
* Excellent communication, project management, and stakeholder coordination skills.
* Proficiency in Microsoft Office and electronic document management systems.
* Ability to work independently and manage multiple priorities in a dynamic environment.
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.