Upcoming Vacancies: GMP Operations Technician (M/F/X)
Company: Inteliphage
- Location: Charleroi, Belgium
- Seniority: Mid level
- Posted: 5 days ago
- Offer language: English
Job description
What your days could look like
Area Maintenance & Organization
- Prepare, maintain and manage the materials, consumables and equipment required for microbiological and bioprocess activities.
- Maintain GMP and cleanroom conditions through routine cleaning, sanitization, equipment sterilization, waste disposal and first-level maintenance.
- Monitor equipment performance, detect drifts or atypical behavior, and react appropriately to protect safety, equipment reliability and product quality.
- Manage consumable inventory and flag the materials required for upcoming production activities.
- Comply with safety rules at all times.
Data, Documentation & Collaboration
- Document all activities accurately and in full GMP compliance, ensuring data integrity in line with ALCOA+ principles.
- Contribute to deviation management, Change Control, CAPA and risk analyses, and take part in investigations to identify root causes and improvement actions.
- Support internal and external audits and inspections by preparing documentation and sustaining compliance.
- Communicate openly and timely with the team, support continuous improvement and the integration of new team members, and maintain the required training level.
Production & GMP Operations
- Contribute to the set-up, qualification and validation of the new GMP production environment (equipment, utilities, processes, cleaning, decontamination, gowning, aseptic process validation, cold chain).
- Participate in the creation and implementation of operational and validation documentation: SOPs, WKIs, batch records and related GMP records.
- Produce commercial batches in full compliance with GMP, aseptic requirements and applicable procedures, autonomously starting up, operating, monitoring and cleaning production equipment.
- Execute USP, DSP and fill & finish activities: bacterial cultures, bacteriophage amplification, clarification, centrifugation, filtration, concentration, purification, formulation and semi-manual filling.
- Perform environmental monitoring in classified areas (particle monitoring, surface sampling, Grade B entry, Grade A manipulations) and apply strict aseptic techniques at all times.
- Handle the associated logistics: inventory, ordering, packaging, shipping, filter testing and material transfers.
- Identify, report and document risks related to safety, quality or timelines, and track process performance through defined KPIs.
What you bring to the table
- Bachelor’s degree in Life Sciences, Microbiology, Biotechnology, or a related field.
- At least 3 years of manufacturing experience in microbiology and/or bioprocessing.
- A MUST: Working experience in GMP classified areas from Grade B to D, applying rigorous, meticulous, and standardized working methods to ensure product quality as well as personnel health and safety on the production area.
- Knowledge of data integrity requirements in regulated environments.
- Proven experience with aseptic techniques is a plus.
- Broad knowledge of concepts, practices, and procedures used in GMP facilities.
- Knowledge of bacteriophages and phage‑based processes is an advantage.
- Well organized, detail oriented, and able to implement and maintain routine laboratory or production programs.
- Clear and concise communication skills with strong interpersonal abilities.
- Ability to work effectively within a multidisciplinary team.
- Written skills in English
- MUST have a valid work permit for Belgium.
- Work to be performed on site