Pharmaceutical Process Technician

at  Ipsen Biopharm Ltd

We are thrilled to announce an exciting opportunity at our Wrexham site as a Pharmaceutical Process Technician (PPT) within our Biofill team. This permanent position involves carrying out manufacturing activities and simple maintenance tasks that contribute to the Fill and Finish processing stages of all products in the production area, primarily in Biofill but also supporting other manufacturing areas. The role requires implementing best practices where applicable, utilizing lean manufacturing philosophies, and fulfilling all cGMP and HSE requirements. The position offers annualized hours, working from 6am to 10pm Monday to Friday, with 13 weekend shifts per year, which are paid at a shift premium. This is a fantastic chance to join a dynamic team and make a significant impact on our production processes.

• Manufacturing Operations: This includes component transfer and preparation, formulation and final filtration of the bulk solution, vial filling and lyophilisation, vial capping, and cleaning of equipment and rooms. All activities must be documented in real time and comply with Ipsen Quality Assurance systems and regulatory standards.
• Preventative Maintenance: Execute simple preventative maintenance procedures on manufacturing process equipment to minimize downtime. This includes equipment like the filling line, freeze driers, autoclave, and vial capper.
• Facility Monitoring and Maintenance: Support the monitoring and maintenance of the facility and direct utilities to ensure compliance. This involves sampling WFI user points, completing environmental monitoring in clean rooms, and responding to particulate monitoring or pressure alarms.
• Process Monitoring and Improvement: Participate in process monitoring and continuous improvement projects using methodologies like Lean 6 Sigma. This includes monitoring process performance, identifying risks and opportunities, applying analytical skills to find solutions, and participating in improvement projects.
• Inspection Readiness: Maintain a constant state of inspection readiness through participation in zone ownership schemes, self-inspections, and mock and formal inspections.
• Team Collaboration: Work cooperatively to ensure good team working, demonstrating effective communication skills, a collaborative approach, and support for team members.
• Quality Systems and Compliance: Play an operational role in site processes such as unplanned events, corrective/preventive actions (CAPA), change control, and internal auditing. Ensure compliance with GMP/EHS requirements and report any compliance concerns.
• Training and Safety: Ensure all training is up to date and documented, and work in a safe manner at all times, raising any health and safety concerns to the appropriate team.

ESSENTIAL REQUIREMENTS:

• Minimum A level or HND in an appropriate disciple
• Manufacturing/ technical experience and competency associated with cGMP Aseptic Filling Facilities
• Knowledge of cGMP documentation completion and prodecure writing
• Knowledge of MHRA and FDA regulations and guidelines
• Computer skills including Excel, Word and PowerPpoint
• Knowledge of EHS guidelines and risk assessments

• Manufacturing Operations: This includes component transfer and preparation, formulation and final filtration of the bulk solution, vial filling and lyophilisation, vial capping, and cleaning of equipment and rooms. All activities must be documented in real time and comply with Ipsen Quality Assurance systems and regulatory standards.
• Preventative Maintenance: Execute simple preventative maintenance procedures on manufacturing process equipment to minimize downtime. This includes equipment like the filling line, freeze driers, autoclave, and vial capper.
• Facility Monitoring and Maintenance: Support the monitoring and maintenance of the facility and direct utilities to ensure compliance. This involves sampling WFI user points, completing environmental monitoring in clean rooms, and responding to particulate monitoring or pressure alarms.
• Process Monitoring and Improvement: Participate in process monitoring and continuous improvement projects using methodologies like Lean 6 Sigma. This includes monitoring process performance, identifying risks and opportunities, applying analytical skills to find solutions, and participating in improvement projects.
• Inspection Readiness: Maintain a constant state of inspection readiness through participation in zone ownership schemes, self-inspections, and mock and formal inspections.
• Team Collaboration: Work cooperatively to ensure good team working, demonstrating effective communication skills, a collaborative approach, and support for team members.
• Quality Systems and Compliance: Play an operational role in site processes such as unplanned events, corrective/preventive actions (CAPA), change control, and internal auditing. Ensure compliance with GMP/EHS requirements and report any compliance concerns.
• Training and Safety: Ensure all training is up to date and documented, and work in a safe manner at all times, raising any health and safety concerns to the appropriate team