Upcoming Vacancies: GMP Operations Technician (M/F/X)

Biopark; Henegouwen; Sur place; EUR 42 000 - 68 000; Plein temps

Avantages offerts par ce poste

GMP compliant environment

Career development in GMP

Résumé du poste

Biopark in Belgium seeks a GMP Operations Technician to participate in Upstream Processing (USP), Downstream Processing (DSP), fill and finish, and logistics activities, with a strong hands-on focus on the launch and development of a new GMP production environment.

You will work closely with the GMP Operations team and Phage Specialists to execute and follow up on operational activities, ensuring quality and data integrity.

Qualifications

• Bachelor’s degree in Life Sciences, Microbiology, Biotechnology, or a related field.
• At least 3 years of manufacturing experience in microbiology and/or bioprocessing.
• MUST have 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.
• MUST have a valid work permit for Belgium.

Responsabilités

• 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.
• 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.
• 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.

Connaissances

GMP operations

Cleanroom operations

Documentation & data integrity

Cross-functional teamwork

Safety compliance

Aseptic techniques

Problem solving

Communication

Formation

Bachelor’s degree in Life Sciences, Microbiology, Biotechnology, or a related field

Description du poste

As a GMP Operations Technician, you will be involved in Upstream Processing (USP), Downstream Processing (DSP), fill and finish, and logistics activities, with a strong hands‑on focus on the launch and development of a new GMP production environment.You will work closely with the GMP Operations team and a team of Phage Specialists to execute and follow up on operational activities related to phage manufacturing. In addition to operational work, you will ensure that the GMP area and adjacent areas are well maintained and operated in accordance with quality and safety standards.

• 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.
• 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.
• MUST have a valid work permit for Belgium.

TAILLE