Technical Operations 1 - Scope of Team Interaction • Learns team effectiveness and communication skills • Works as team member • Resource Management • Manages own time and professional development • Accountable for own results • Breadth and Depth of Knowledge • Develops and applies fundamental knowledge and skills in procedures, techniques, tools, materials and/or equipment needed for position • Focused on a limited range of activities • Complexity of Technical Knowledge • Completes routine tasks consisting of a series of prescribed steps within agreed timeframe • Tasks may be embedded in Standard Operating Procedures, operational and technical work practices and guidelines • Learns to identify process issues • Innovation and Risk-Taking • Demonstrates receptiveness to new processes and ideas • Knowledge Sharing • Learns the work processes and the business within own area • Complexity of Problem Solving • Identifies and solves routine problems that involve direct application of skills/knowledge in a structured environment • Seeks the input and assistance of others • Impact of Decisions • Decisions impact own work • Judgment • Significant reliance on supervisor • Does not require deviation from established and well-defined procedures and practices • Consults with others to ensure quality of judgment • Direction Received • Completes assignments under close supervision and/or detailed instruction in a structured environment • Review of Work • Work is closely reviewed • Compliance • Learns and is accountable for adhering to Client standards, guidelines and values
ORGANIZATIONAL RELATIONSHIPS • Functional support groups include Quality Assurance, Quality Control, Validation, Tech Transfer, and Quality Engineering.
Cell Culture Technician:
Scope of Team Interaction • Learns team effectiveness and communication skills • Works as team member Resource Management • Manages own time and professional development • Accountable for own results Breadth and Depth of Knowledge • Develops and applies fundamental knowledge and skills in procedures, techniques, tools, materials and/or equipment needed for position • Focused on a limited range of activities Complexity of Technical Knowledge • Completes routine tasks consisting of a series of prescribed steps within agreed timeframe • Tasks may be embedded in Standard Operating Procedures, operational and technical work practices and guidelines • Learns to identify process issues Innovation and Risk-Taking • Demonstrates receptiveness to new processes and ideas Knowledge Sharing • Learns the work processes and the business within own area Complexity of Problem Solving • Identifies and solves routine problems that involve direct application of skills/knowledge in a structured environment • Seeks the input and assistance of others Impact of Decisions • Decisions impact own work Judgment • Significant reliance on supervisor • Does not require deviation from established and well-defined procedures and practices • Consults with others to ensure quality of judgment Direction Received • Completes assignments under close supervision and/or detailed instruction in a structured environment Review of Work • Work is closely reviewed Compliance • Learns and is accountable for adhering to client standards, guidelines and values
EDUCATION AND EXPERIENCE • Must-Have
- High School Diploma or GED • Nice-to-Have
- Bachelor's Degree
- Basic mechanical knowledge and experience in using hand tools.
- Manufacturing experience in a Good Manufacturing Practices (cGMP) or another regulated environment.
TECHNICAL SKILLS REQUIREMENTS • Basic understanding of Good Manufacturing Practices (GMP).
PHYSICAL POSITION REQUIREMENTS • Requires the moving of heavy equipment and the ability to lift ~50 pounds. The incumbent needs to take the necessary safety precautions when working with pressurized systems, steam, and corrosive chemicals. • The incumbent is required to attain detail knowledge of the operational equipment. • The incumbent will be required to solve problems regarding site assessment, specific units used in Biopharmaceutical manufacturing. • The incumbent must be able to express ideas into SOPs, MFRs and be able to use a multitude of programs including Excel, Word, Power Point, etc.