| Role and Context |
| Position | Process Engineer |
| Reporting Position | Reporting to applicable Manager/Team Leader of the area |
| Working Relationship | - Supporting Manufacturing areas and all support departments
- Key Internal Contacts: Manufacturing, QA, QC, Validation, Regulatory, EHS, Program Management and Finance
- Key External Contacts: Equipment vendors, component suppliers, other Genzyme sites, Development pharmaceutics groups and benchmarking organisations
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| Purpose of Role | - Provide leadership and support to operations teams to ensure appropriate standards are met
- Development and implementation of improvement initiatives in all manufacturing and development operations
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| Need to Do |
| Job Requirements | - Liaise with external and internal customers, suppliers and agencies to define and improve manufacturing and development operations
- Optimisation of manufacturing and development operations
- Identification & implementation of opportunities for improvements
- Assist in the implementation of capital projects
- Act as process lead for inspection development
- Lead technical problem resolution & RCA for all manufacturing operations, in conjunction with cross functional teams.
- Implementation and monitoring of performance metrics
- Lead cycle time reduction initiatives in conjunction with manufacturing teams
- Implementation of best practice
- Process development programme design / plant trials, execution and implementation
- Constantly seeking to challenge operational standards and driving continuous improvement.
- Ability to multi task and prioritize workload.
- Maintain required quality documents in a current compliant state.
- Subject Matter Expert for and team resource for new product introductions / enhancement development projects
- Resource for Clinical supply provision projects
- Aseptic manufacture or oral dose manufacture context
- Subject Matter Expert for product quality attributes and process critical parameters
- Design and execution of experimental programmes
- Operation of process laboratories
- Scale-up and technology transfer project role
- Liaison for Clinical supply provision projects
- Liaison for New formulation and product enhancement programmes
- Technical representative for assessment and development of process change control and regulatory submission proposals
- Technical support and trouble-shooting in support of manufacturing activities
- Process/product deviation investigation and resolution
- Technical report writing
- Training delivery of technical training programmes
- Support of process qualification and process validation activities as required
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| Compliance Related Tasks | - Complaints, LCRs, Deviations, CAPAs support ensuring effective RCA Smart CAPA's and on time closure
- Attainment of SMART goals.
- Reduction in process cycle-times.
- Ensure compliance to cGMP at all times
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| Need to Know |
| Qualifications | - Degree in Chemical, Industrial or equivalent Engineering discipline
- Advanced degree in Pharmaceutics, Pharmacy or related science discipline considered an advantage
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| Experience | - 2 years + experience within Pharmaceutical Development and Manufacturing environment
- OEE/SMED/RCA/CI experience.
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| Skills and Knowledge | - Technical knowledge(theory and practice) of aseptic manufacturing including lyophilisation considered an advantage
- Design of Experiment and associated statistical techniques
- Pharmaceutical product development project life-cycle
- Strong report-writing and verbal communication skills
- Laboratory and pilot plant skills
- Research skills
- Innovation and creativity skills
- Project management skills
- Structured Problem-solving skills - Statistical
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| Designation Duty | May be required to deputise for Team Leader / Manager if required |
| Personal Characteristics | - Creative and innovative approach
- Ability to interact effectively in multi-disciplinary teams
- Strong team player ("Owl" characteristics)
- Seeing tasks through to successful completion
- Excellent communicator
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