GMP Phage Manufacturing Technician

Biopark; Henegouwen; In loco; EUR 42.000 - 68.000; Tempo pieno

Vantaggi offerti da questo lavoro

GMP compliant environment

Career development in GMP

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

GMP operations

Cleanroom operations

Documentation & data integrity

Cross-functional teamwork

Safety compliance

Aseptic techniques

Problem solving

Communication

Formazione

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

Descrizione del lavoro

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.