Manufacturing Associate

Job Responsibilities:

• Manage own time and professional development, be accountable for own results and begin to prioritize own workflow.
• Cross-functional communication with tech transfer team, quality and engineering as necessary.
• Implement {Current} Good Manufacturing Practices, part of GxP} procedures and safe handling techniques for solid dosage processing within the continuous manufacture /PCMM work stream.
• Perform Upstream and Downstream operations in clinical Bio-Manufacturing.
• Ability to follow Standard Operating Procedures and work under minimal supervision.
• Identify and support continuous improvement initiatives and root cause analysis tools.
• Generate, assist and execute documentation associated with solid dosage manufacture, such as, working batch record documentation, in-process run sheets.
• Complete activities identified as Operator care tasks associated with the maintenance and operation of complex pharmaceutical manufacturing equipment.
• Work in electronic systems including QMS, Documentation, Laboratory Information Management System Enterprise Resource Planning (e.g. SAP) etc.
• Actively participate in shift exchange activities and communication channels.
• Complete training to take part in safety inspections within the facility.
• Understand and comply with the policies, procedures and working practices of Environment, Health & Safety and where necessary contribute to the review and implementation of the practices in the plant.

Skills:

• Demonstrated experience in a biotechnology manufacturing or laboratory environment
• Operational knowledge of computerized systems, Familiarity with Production Control Systems, Enterprise Resource Planning Systems and other business systems
• Maintains a safe work environment
• Demonstrated capability to work as a team member in a matrix development team
• Excellent oral and written communication skills
• Strong computer skills in Microsoft Office required, especially MS Word, MS Excel
• Understanding scientific principles, ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Knowledge of cell culture and downstream processing techniques

Education/Experience:

• High School Diploma or GED