Job Title: Process Technician
Position Reports to: Shift Operations Supervisor
Your role will be in one of the Shift Operating Units at Grange Castle where you will be directly involved in the manufacture of one of our products, ensuring that they meet all specifications for safety, potency, and efficacy. You will work within the guidelines of cGMP to ensure conformance with all regulatory requirements and site SOPs, while assisting in the improvement of all current processes through our Continuous Improvement Program.
• Responsible for execution of all tasks associated with the preparation for and production of Pfizer products in cGMP environment ensuring full attention to detail and excellent documentation skills.
• Assist in maintaining a safety orientated Culture, cGMP compliant work environment at all times
• Responsible for completion of tasks according to SOPs and batch records (paper and electronic).
• Perform initial troubleshooting of issues identified during routine operations.
• Assist with the investigation of and operations deviations through Quality System, engaging with all relevant personnel and functions as appropriate.
• Assist where necessary with the training and mentoring of colleagues in SOPs, process execution and equipment operation.
• Provide input into the creation and maintenance of area SOPs and batch records.
• Seek opportunities for Continuous Improvement and embrace Pfizer’s ‘Own It’ culture to own and drive any activities associated with delivering these improvements.
• Use Lean Tools as part of daily operations (Standard Work, TPM, 5S, Method 1, 2 etc) to optimize efficiency and drive the culture of Continuous Improvement and Zero Defects
• Where necessary assist in any in Facility and Equipment start up and Validation activities. Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products into sustaining operations.
• Write, review, revise and approve manufacturing documentation as necessary. This includes Policy documents, Standard Operating Procedures (PPM format), Work instructions, Logbooks and Batch Records.
To be successful in this role you will require:
• Certificate, Diploma, Degree, Trade qualification or equivalent is essential
• Minimum 2 years’ experience in a biopharmaceutical or pharmaceutical cGMP manufacturing
• Experience executing operations in accordance to SOPs, Batch Record (Paper or Electronic) and Manufacturing Controls Systems (Delta V or Unicorn) is essential
• Experience to include activities such as Clean in Place/Steam in Place Systems, Washers, Autoclaves, Large and Small Buffer/Media Preparation, Cell Culture, Harvest, Ultrafiltration/Diafiltration, Chromatography, Sterile Filtration, Manual and Automated Filling Systems
• An ability to work independently, and as a member of a self – directed shift team in a dynamic, fast-paced environment that requires flexibility and initiative
• Experience in training Technicians and troubleshooting equipment and/or processing issues during commissioning, startup, validation and cGMP production in clean rooms with Grade C/D gowning requirements.
• Participation in Regulatory Inspection representing Operations, presented process information to Inspectors preferred
• Lean experience using Standard Work, TPM and 5S
• Six Sigma experience applying Method 1, 5 Whys, knowledge of or has been a member of Green Belt / Black Belt project teams preferable
• Computer skills such as Microsoft Office (excel, word, power point, access, outlook) and Minitab (or equivalent data analytics) preferable
• Excellent interpersonal skills, positive influence, team orientation, attention to detail, documentation skills, problem identification and problem solving skills.