Support Key Activities within the Process Engineering Dept.
Assist with the execution of equipment / process qualifications as required.
Read and understand the execution of validation documentation protocols and summary reports.
Assist with the implementation of equipment and/or process changes in line with the necessary change control process.
Participate in the efforts towards continuous improvement on quality, service, HSE and costs, to achieve state-of-the-art manufacturing processes.
Participate with the modifications, improvements, or validations of existing or new products, processes, tooling, equipment.
Review processes continually to ensure their quality and efficiency.
Participate in process improvement projects.
Work closely with Process Engineering on the introduction of new equipment or technology.
Assist with ‘trouble shooting’ improvements when required in production.
Review process engineering documentation and safeguard confidential information.
Work within formal systems, such as cGMP, ISO, CE to ensure that new processes and improvements conform with quality and legal requirements.
Support to the Global (Process) Engineering group. Support local projects to implement the Global PE initiatives.
Ensure that all projects and activities are in compliance with local, regional and best practice requirements on HSE and meet authority requirements.
Keep Process Engineering manager advised of any unusual situation which might impair or affect safety, quality, production output or assigned projects.
Transfer of process knowledge to Operations Group as required.
Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
Compliance to all local site Environmental, Health and Safety regulations.
Compliance to all local site company policies, procedures and corporate policies
Other duties as assigned
Preferred Knowledge, Skills and Abilities
2+ years’ experience in a similar position within the manufacturing industry, ideally in a regulated industry.
Basic knowledge of LEAN 6 sigma manufacturing principles
Yellow belt of higher an advantage.
Experience with continuous improvement of processes and validations of processes/equipment
cGMP experience is an advantage.
Self-motivated, results- and solution-oriented personality
Well-developed communication and interpersonal skills.
Good organizational and project management skills.
Highly analytical and structured way of working
Experience with drafting and execution of validation protocols and associated documentation.
Knowledge of CAPA systems and use of formal problem-solving tools.
Physical Requirements
Light-Exerting up to 20lbs/9kg of force frequently, and/or negligible amount of force frequently constantly to move objects.