Role and Context
PositionProcess Engineer
Reporting PositionReporting 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
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
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
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
Need to Know
Qualifications
* Degree in Chemical, Industrial or equivalent Engineering discipline
* Advanced degree in Pharmaceutics, Pharmacy or related science discipline considered an advantage
Experience
* 2 years + experience within Pharmaceutical Development and Manufacturing environment
* OEE/SMED/RCA/CI experience.
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
Designation DutyMay 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