- Localisation : Berne, Suisse
- Poste : Process Validation Engineer (Pharma/Biotech)
- Sector: Life Science
- Type de contrat : Permanent contract
- Date de démarrage : ASAP
Agap2 is a European engineering and operational consulting group founded in 2005 and specialized in industry. We operate in the Pharmaceutical, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.
As a consultant, you will support our clients in the successful execution of their projects by providing your technical expertise and engineering know-how.
You are adaptable, proactive, and motivated to work in diverse industrial environments, contributing to high-impact engineering projects for leading international companies.
We are currently looking for a Process Validation Engineer to support process validation activities for pharmaceutical and biotechnology manufacturing facilities in Switzerland. This position focuses on ensuring manufacturing processes are validated and maintained in compliance with GMP requirements throughout the product lifecycle, from process development to commercial production.
Vos missions principales sont :
Process Validation
- Develop, review, and execute Process Validation Master Plans (PVMPs), validation protocols (IQ/OQ/PQ/PPQ), and validation reports.
- Lead process validation activities for new manufacturing processes, process transfers, and lifecycle management.
- Support process performance qualification (PPQ) campaigns and continued process verification (CPV).
- Perform risk assessments (FMEA, process risk analysis) to define validation strategies and acceptance criteria.
- Ensure validation activities comply with GMP requirements, regulatory guidelines, and client quality standards.
Project Execution
- Collaborate with cross-functional teams including Manufacturing, MSAT, Engineering, Quality Assurance, Quality Control, and Regulatory Affairs.
- Support commissioning and qualification activities to ensure process readiness before validation.
- Participate in Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), equipment qualification, and startup activities when required.
- Provide technical support during process implementation, technology transfers, and commercial manufacturing.
- Contribute to project planning and ensure validation deliverables are completed according to project timelines.
Continuous Improvement & Compliance
-
- Analyze validation and manufacturing data to identify opportunities for process optimization and continuous improvement.
- Investigate process deviations, support CAPA implementation, and contribute to change control activities.
- Maintain validation documentation in accordance with GMP requirements and company quality systems.
- Support internal and external audits and regulatory inspections by providing validation documentation and technical expertise.
- Work closely with project managers, clients, and manufacturing teams to ensure compliant and efficient process validation activities.
Ce poste est fait pour vous si...
- Master’s degree in Biotechnology, Chemical Engineering, Pharmaceutical Sciences, Process Engineering, Life Sciences, or a related scientific discipline.
- Minimum 3 years of experience in process validation, manufacturing science, validation, or pharmaceutical manufacturing within the pharmaceutical, biotechnology, or life sciences industry.
- Experience with sterile manufacturing, biologics, vaccines, or API manufacturing is considered an asset.
- Experience working within engineering consulting or supporting multiple client projects is an advantage.
- Strong knowledge of GMP regulations, Annex 15, FDA Process Validation Guidance, and pharmaceutical validation principles.
- Experience developing and executing validation protocols and reports (IQ/OQ/PQ/PPQ).
- Knowledge of process lifecycle validation, continued process verification (CPV), and statistical analysis of process performance.
- Experience with deviation investigations, CAPAs, change controls, and risk management methodologies.
- Familiarity with commissioning and qualification activities is a plus.
- Fluent English; a fluent German level is also mandatory.
Nous rejoindre, c’est...
-
- Joining a group with strong development potential that aims to improve your employability on challenging and varied projects.
- Joining a structure that has been established in Switzerland for a long time with a client portfolio that includes leaders in the sector.
- Having a sustainable job with stability and access to a real collaboration.
- Benefit from training with accredited and certified centers.
- Having a local management team to support you in the achievement of your missions and in the development of your career.
- Being part of a dynamic, committed team with real human values that we live by every day.
Only applications from Swiss and EU citizens will be considered. Please note that due to Brexit we are no longer accepting applications from the UK.