ODF Coating Machine Operator

AlRazi Pharmaceutical Industries Factory Co; Dammam; On-site; SAR 48,000 - 120,000; Full time

Job summary

Ein innovatives Unternehmen in der Pharmaindustrie sucht einen engagierten Maschinenbediener für die ODF-Beschichtungsmaschine. In dieser spannenden Rolle sind Sie verantwortlich für den Betrieb und die Überwachung der Maschine, die Einhaltung von cGMP-Richtlinien und die Durchführung von In-Prozess-Kontrollen. Sie werden Teil eines dynamischen Teams, das sich auf Qualität und Effizienz konzentriert. Wenn Sie eine Leidenschaft für die pharmazeutische Produktion haben und in einem kontrollierten Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie, Ihre Fähigkeiten einzubringen und weiterzuentwickeln.

Qualifications

• Mindestens 3 Jahre Erfahrung in der pharmazeutischen Produktion, insbesondere mit Beschichtungs- und Trocknungsanlagen.
• Technisches Diplom in Maschinenbau, Elektrotechnik oder Mechatronik erforderlich.

Responsibilities

• Betrieb und Überwachung der ODF-Beschichtungsmaschine gemäß den SOPs.
• Durchführung von In-Prozess-Kontrollen und Dokumentation der Ergebnisse.

Skills

Maschinenbetrieb

Fehlerbehebung

Dokumentation

Qualitätskontrolle

Teamarbeit

Education

Technisches Diplom in Maschinenbau

Erfahrung in pharmazeutischen Produktionsabläufen

Tools

ODF-Beschichtungsmaschine

Batch-Dokumentationssysteme

Job description

Job Objective:

• To operate, monitor, and maintain the ODF coating machine in alignment with the batch production plan, ensuring compliance with cGMP, product quality, and production efficiency standards.

Duties, Responsibilities and Authorities:

• Machine Operation & Process Control
• Operate the ODF coating machine as per validated SOPs and approved batch records.
• Monitor critical process parameters (e.g., coating speed, temperature, drying time) and promptly report deviations.
• Verify and countercheck the received ODF solution from the preparation area before coating.
• Perform in-process checks such as film thickness, weight, and uniformity and coordinate with IPQA for sample collection.
• Conduct basic troubleshooting and adjustments during operation to minimize machine stoppages.
• Cleaning, Maintenance & Documentation
• Perform routine cleaning and sanitation of the machine before and after batch runs, ensuring line clearance and readiness.
• Carry out basic preventive maintenance tasks and report abnormalities to the Engineering Department.
• Maintain accurate entries in logbooks and batch production records (BPR), including equipment usage, cleaning, and maintenance logs.
• Compliance & GMP Practices
• Adhere to cGMP, SFDA guidelines, and internal SOPs at all times during machine operation.
• Ensure proper status labeling of the machine and working area at each stage.
• Report and escalate any OOS/OOT/deviations observed during the coating process.
• Communication & Teamwork
• Coordinate with engineering, IPQA, and ODF preparation teams to ensure smooth workflow.
• Provide support during validation and qualification activities for ODF batches and equipment.
• Support other packaging or coating operations as instructed by the ODF Line Leader or Production Manager.

Education/Licensure:

• General Education/Licensure:
• Minimum Requirement: Technical Diploma in Mechanical, Electrical, or Mechatronics Engineering.
• Preferred: Exposure to pharmaceutical manufacturing operations and understanding of sterile/non-sterile production principles.

Professional Experience:

• Minimum: 3 years of relevant experience in pharmaceutical production, preferably with experience on coating, drying, or film forming equipment.
• Preferred: Experience with Orally Dissolvable Films (ODF) or similar continuous film production systems.

Core Competencies:

• Proficiency in machine operation and troubleshooting.
• Basic understanding of batch documentation and GMP compliance.
• Strong attention to quality, cleanliness, and safety.
• Ability to work independently and with minimal supervision.
• Effective communication and coordination skills.
• Flexible to perform multi-tasking duties in ODF and related production activities.

Work Conditions:

• Required to work in controlled environments with gowning protocols.
• Work may involve standing for extended periods and handling of film rolls, solvents, and machinery.
• Shift-based work depending on production scheduling.