Manufacturing Specialist

Imagining a better tomorrow is at the heart of our work. A global network of biopharma companies relies on us to deliver life-changing therapies.

At PCI, we invest in individuals who drive progress and create value. Our strategy involves building cross-functional teams to pioneer new approaches and shape the future.

Key Responsibilities:

• Complete or lead training requirements in accordance with established curricula and other necessary training.
• Ensure compliance with EHS regulations, including reporting non-compliance formal notifications.
• Verify Batch Records have been approved and QA issued prior to use.
• Maintain a high level of personal hygiene as required in pharmaceutical environments.
• Adhere to safety protocols, gowning, and hygiene requirements.
• Monitor production conditions and adjust accordingly to meet production requirements.
• Follow procedures for filling and filtering while calculating dilutions, concentrations, and yields.
• Use ability to complete tasks efficiently and safely.
• Communicate issues effectively to Supervisors.
• Assist in identifying and implementing continuous improvement opportunities.
• Verify batch record execution and log book documentation for accuracy and detail.
• Operate and maintain pharmaceutical production machinery, executing procedures for manufacturing such as dispensing, mixing coating, encapsulating, granulating, drying, milling, blending, compressing, and the like.
• Identify and assist in corrective actions for processing-related issues.
• Support on-the-job training for production trainees and operators.
• Collect in-process and QC/RS samples as per the MBR.
• Provide shop floor supervision and general production updates (e.g., shift reports) to Supervisors.
• Lead production assistants in manufacturing and following procedures stated in the batch record.
• Verify released or provisional released materials for manufacturing, setting up equipment, ensuring all batch-required equipment is calibrated, annotated within batch record, equipment register when applicable.
• Report and resolve production issues regarding equipment or formulation with consultation of Production, QA, Project Managers.
• Verify bulk and finished products against Batch Records or alternative documentation.
• Ensure that samples are taken and recorded in accordance with SOPs, relevant Forms, batch record instructions (e.g., QC samples and retention samples).
• Verify relevant inventories specified in the MBR.
• Review production batch records ensuring completion and signature by all participating individuals prior to Production Supervisor review.
• Report production deviations to Production Supervisors/Production Managers.
• Clean facility and equipment in accordance with SOPs, relevant Forms, batch record instruction.
• Ensure production facilities are clean prior to commencement via logs and registers.
• Dispose of waste materials and rubbish from production into the correct bins, supporting recycling.
• Provide detailed hand-over to incoming shifts within applicable manufacturing areas.
• Ensure detailed end-of-shift hand-over to Production Associate, Shift Supervisor.
• Ensure equipment has been cleaned before commencement in accordance with SOPs.
• Ensure equipment calibration and records kept/register updated.
• Comply with label approval forms, label content, and randomization lists before commencing batch manufacture.
• Prepare, review, and maintain SOPS relevant to the manufacturing facility.
• Review batch records providing ongoing feedback to Production and Project Managers.
• Participate in PCI internal audits and third-party audits and respond to audit findings and product complaints/recalls as needed.
• Assist other departments as directed when and where required.