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- Previous new product development and/or manufacturing experience in medical / pharmaceutical industries a distinct advantage; in particular strong knowledge and application of process and equipment validation techniques, PFMEA’s, and associated regulatory requirements and applies this knowledge in the efficient & timely validation of equipment and processes.
- Demonstrates basic technical expertise on process/product technologies to support design, optimisation, validation and troubleshooting of those technologies.
- Demonstrates good working knowledge of Six Sigma methodologies and with mentor assistance, applies these tools in the characterization, optimization and troubleshooting of process equipment and technology performance.
- With mentor assistance demonstrates good working knowledge and application of Lean methodologies, and process improvement tools to assist in identification and elimination of “waste” process steps and development of efficient, cost effective equipment and processes.
- Under supervisory direction, provides input to Equipment engineering or external equipment/tooling or material vendors in the selection, design & development of new (or upgrades to existing) equipment, tooling and materials.
- Supports the development and execution of experimentation and testing to enable characterisation, optimization and troubleshooting of processes and equipment and summarises, analyses and draws conclusions from test results leading to effective technical resolution.
- Supports the introduction of new processes, equipment and materials including installation, calibration, EHS assessment debug, and all associated process and quality system documentation requirements including technical and process work instructions.
- Under supervision supports the writing and release of process validation documentation including FMEA’s, Validation Plans, protocols and reports.
- Under supervision, supports execution and documentation of validation builds, co-ordinates testing of validation units and compiles, analyses and reports on the validation results.
- With mentor assistance ensures compliance with all the regulations governing the quality systems.
- Travel to other sites / vendors as part of Technology development & transfer activities.
Quality System Requirements
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
Job Scope and Levelling Guidelines
An entry level professional. General knowledge and application of technical and business concepts, procedures, and practices. Interprets company policies and procedures to resolve issues. Beginning knowledge of industry practices and standards.
Applies professional concepts and company policies and procedures, analyses data or situations, and exercises judgment to recommend solutions to solve problems. Follows standard practices and procedures in analysing situations or data from which answers can be obtained.
Planning and Organization
Plans, organizes, and prioritizes own daily work routine to meet established schedule with guidance from manager.
Discretion/Latitude; Supervision Received; Decision Making
Receives general supervision. Makes recommendations which may be reviewed by manager. May exercise authority within limits. May seek guidance in resolving problems.
Business Relationships and Project Management
Begins establishing and cultivating internal business relationships to facilitate completion of tasks. May participate in project teams
Minimum Education and Experience
- Honours Degree – HETAC Level 8 in relevant Technical discipline
- Minimum of 18 months post graduate experience.
- Strong technical experience preferably in the health care industry
- Excellent interpersonal and communication skills.
- Excellent analytical and problem-solving skills.
- Candidates should have a proven track record of working in a fast-paced environment with strong technical capabilities and be capable of handling multiple development aspects of assigned projects.