Upcoming Vacancies: GMP Operations Technician

Il y a 5 heures

Charleroi, Région wallonne, Belgique Inteliphage Temps plein

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